AGENT

Report

• Report Number: 2124215-2026-21480
• Event Type: Death
• Date Received: April 21, 2026
• Report Date: April 21, 2026
• Manufacturer: BOSTON SCIENTIFIC CORPORATION
• Product Code: OOB
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

REPORTING QUARTER: JANUARY 1, 2026 TO MARCH 31, 2026. THIS REPORT SUMMARIZES 203 DEATH EVENTS FOR ALL BSC DEVICES REPORTED IN THE ACC CATHPCI REGISTRY. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. DEVICES REPORTED FOLLOWED BY THE PROCODE: AGENT, OOB, EMERGE, LOX, NC EMERGE, LOX, ROTAPRO, MCX, SYNERGY MEGATRON, NIQ, SYNERGY XD, NIQ, TAPPER EXCHANGE DEVICE, DQY, WOLVERINE CORONARY CUTTING BALLON, NWX. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. HOWEVER, THE EVENTS REPORTED WERE ANTICIPATED IN NATURE AS DEFINED BY THE "POTENTIAL ADVERSE EVENTS" LIST IN THE FDA-APPROVED INSTRUCTIONS FOR USE (IFU). NO NEW RISKS OR INCREASE IN ADVERSE EVENT RATES WERE IDENTIFIED WITH RESPECT TO THE AGENT DCB DEVICE BASED ON THE DATA RECEIVED FROM THE ACCF CATHPCI NCDR. THERE ARE NO CHANGES IN BENEFIT/RISK OF THE AGENT DCB DEVICE, WITH RESPECT TO COMPLAINTS RESULTING IN SERIOUS INCIDENTS. PER INTERNAL PROCESSES, BSC REGULARLY CONDUCTS CLINICAL TRIAL SAFETY REVIEW (CTSR) MEETINGS TO ASSESS AND DISCUSS CLINICAL DATA INPUTS (INCLUDING, BUT NOT LIMITED TO SAFETY TRIGGER, UADES/USADES, SERIOUS (PUBLIC) HEALTH THREATS, ADVERSE EVENTS, AND DEVICE DEFICIENCIES). THE TRANSFERRED NCDR EVENT DATA ARE ASSESSED FOR ESCALATION AT REGULAR INTERVALS DURING CTSR MEETINGS AND MEASURED AGAINST SAFETY TRIGGERS GENERATED FROM HISTORICAL DATA (AGENT IDE DCB ARM). RISK/BENEFIT PROFILE: PUBLICATIONS OF 0-30 DAYS POST-PROCEDURE EVENT RATES FROM THE LITERATURE AND NATIONAL SWEDISH REGISTRY (SCAAR), AS WELL AS SUPPLEMENTAL DATA ON 2ND GENERATION DRUG-ELUTING STENTS (WHERE NO DATA ON AGENT OR COMPETITOR DCB WERE AVAILABLE) HAVE REPORTED RATES OF ALL-CAUSE DEATH FROM 0 - 3.5%, MYOCARDIAL INFARCTION FROM 0-1.7%, TVR FROM 0-1.7%, CARDIAC ARREST FROM 0.2-2%, ALL BLEEDING FROM 1.1-6.67%, AND STROKE OF 1.6%. NOTE: THE REPORTED RATES FROM THESE SOURCES OCCURRED FROM 0 TO 30 DAYS POST-PROCEDURE, AS PROCEDURE-ONLY TIMEPOINT DATA HAS NOT BEEN RECORDED IN THE LITERATURE. EVENT RATES OBSERVED IN PATIENTS WITH AGENT DCB USE PLUS A BSC ANCILLARY DEVICE(S) WERE COMPARED TO EVENT RATES AVAILABLE IN CLINICAL STUDIES, LITERATURE, AND/OR COMPARABLE REAL-WORLD DATA USING THE PINC AI HEALTHCARE DATABASE (PHD) FOR THE ANCILLARY DEVICE FAMILIES OF APEX (NO DATA AVAILABLE), EMERGE, PROMUS DES, SYNERGY DES, ANGIOJET, AND FILTERWIRE. EVENT RATES OBSERVED IN PATIENTS WITH AGENT DCB USE PLUS A BSC ANCILLARY DEVICE(S) WERE COMPARED TO EVENT RATES AVAILABLE IN COMPARABLE REAL-WORLD DATA USING PHD FOR THE ANCILLARY DEVICE FAMILIES OF NC EMERGE, TRAPPER, WOLVERINE, AND THREADER, AND USING PHD AND SCAAR FOR THE DEVICE FAMILY OF ROTATIONAL ATHERECTOMY. OVERALL, CLINICAL OUTCOMES THROUGH DISCHARGE FROM THE AGENT PAS TRIAL DATASET, PATIENTS WITH AGENT DCB USE PLUS ANCILLARY DEVICE(S), ALIGN WITH EXPECTATIONS OBTAINED FROM THE COMPARATIVE ANALYSIS FOR THE ANCILLARY DEVICE FAMILIES. TOTAL NUMBER OF PATIENTS ENROLLED THROUGH SEPTEMBER 2025: 17850.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;22362368,9/6/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure Gastrointestinal BleedingThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,80,Male,,1/1/2025,,E0506;E0611,F02,A24,G07001,B17,C19,D15,,0;22361270,6/29/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Gastrointestinal Other Vascular Complications RequiringTreatmentThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Female,,1/1/2025,,E0506;E0511,F02,A24,G07001,B17,C19,D15,,0;22360980,9/17/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,56,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22361423,7/14/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,90,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22361445,9/24/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,87,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22361479,7/14/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,90,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22361890,7/3/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,85,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362145,9/12/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Non-cardiovascularprocedure or surgery Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,54,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362146,9/12/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Non-cardiovascularprocedure or surgery Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,54,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362165,8/12/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362224,7/13/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,54,Female,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362258,7/13/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,54,Female,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362282,8/18/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,61,Female,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362400,7/30/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Deathduringprocedure Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,64,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362006,9/2/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cardiovascularprocedure Perforation Cardiac Arrest, CardiacTamponade, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,51,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362250,6/24/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Dissection Heart Failure, CardiacArrest, CardiogenicShock, Myocardial InfarctionThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,71,Male,,1/1/2025,,E0602;E0515;E0611;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22362149,9/1/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,64,Male,,1/1/2025,,E0602;E0611,F02,A24,G07001,B17,C19,D15,,0;22362150,9/1/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,64,Male,,1/1/2025,,E0602;E0611,F02,A24,G07001,B17,C19,D15,,0;22362486,8/30/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Ischemic Stroke, CardiacArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,79,Male,,1/1/2025,,E0602;E013302;E0511,F02,A24,G07001,B17,C19,D15,,0;22361513,9/22/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,80,Female,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22361574,9/22/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,80,Female,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22361676,9/3/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,85,Male,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362063,8/21/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Deathduringprocedure Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,53,Female,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362082,8/21/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Deathduringprocedure Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,53,Female,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362083,7/27/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,86,Male,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362092,8/21/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Deathduringprocedure Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,53,Female,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362139,7/18/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,76,Female,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362402,9/9/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,78,Male,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22360418,8/13/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,75,Female,,1/1/2025,,E0602;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22362064,9/19/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E0602;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22360527,8/4/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiacArrest, CardiacArrest, Cardiac Arrest, NewRequirement for DialysisThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,72,Female,,1/1/2025,,E0602;E061202;E1311,F02,A24,G07001,B17,C19,D15,,0;22362158,9/4/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22361927,9/18/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Othernon-cardiovascular reason Cardiogenic Shock, CardiacArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,80,Male,,1/1/2025,,E0602;E233601,F02,A24,G07001,B17,C19,D15,,0;22362220,8/6/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Female,,1/1/2025,,E0602;E0511,F02,A24,G07001,B17,C19,D15,,0;22362329,8/12/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,77,Male,,1/1/2025,,E0515,F02,A24,G07001,B17,C19,D15,,0;22362366,7/21/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Hemorrhage Cardiac Arrest, Hematoma at AccessSite, New Requirement forDialysisThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,64,Female,,1/1/2025,,E0515,F02,A24,G07001,B17,C19,D15,,0;22361677,9/24/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,53,Male,,1/1/2025,,E0611,F02,A24,G07001,B17,C19,D15,,0;22361249,7/1/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure Heart Failure, MyocardialInfarctionThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,81,Female,,1/1/2025,,E0611;E061202,F02,A24,G07001,B17,C19,D15,,0;22361659,6/20/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Heart Failure, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,80,Male,,1/1/2025,,E0611;E233601,F02,A24,G07001,B17,C19,D15,,0;22360551,7/14/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased, OtherCardiovascular Reason Heart FailureThe following event, based on data from the Cath PCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Female,,1/1/2025,,E0611;E0511,F02,A24,G07001,B17,C19,D15,,0;22361590,7/20/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occurred Death at Discharge Deceased,OtherCardiovascular Reason Heart FailureThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,82,Male,,1/1/2025,,E0611;E0511,F02,A24,G07001,B17,C19,D15,,0;22362438,7/14/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased, OtherCardiovascular Reason Heart FailureThe following event, based on data from the Cath PCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Female,,1/1/2025,,E0611;E0511,F02,A24,G07001,B17,C19,D15,,0;22362308,9/2/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas RegistryIt was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Hematoma at Access SiteThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,82,Male,,1/1/2025,,E0505;E0511,F02,A24,G07001,B17,C19,D15,,0;22360964,9/8/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Infection The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Male,,1/1/2025,,E1906,F02,A24,G07001,B17,C19,D15,,0;22361349,7/1/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Ischemic StrokeThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,60,Female,,1/1/2025,,E013302;E061202,F02,A24,G07001,B17,C19,D15,,0;22362302,8/26/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Ischemic StrokeThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,75,Female,,1/1/2025,,E013302;E061202,F02,A24,G07001,B17,C19,D15,,0;22361366,8/28/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,78,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22361381,8/28/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,78,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22361696,7/8/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,49,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22361830,7/3/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,68,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362136,7/29/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,52,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362137,7/29/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,52,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362170,8/28/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,89,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362235,8/16/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,76,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362265,5/20/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,85,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362609,9/9/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas RegistryIt was reported that the following events occureed Death at Discharge Deceased,Acute myocardial infarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,70,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22366031,9/8/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas RegistryIt was reported that the following events occureed Death at Discharge Deceased,Acute myocardial infarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,79,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22366058,9/8/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas RegistryIt was reported that the following events occurred Death at Discharge Deceased,Acute myocardial infarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,79,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22360064,9/12/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22360683,7/22/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Othernon-cardiovascular reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361138,9/17/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Othernon-cardiovascular reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,75,Female,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361255,7/5/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,69,Female,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361276,7/5/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,69,Female,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361308,9/3/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,72,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361326,8/25/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Othernon-cardiovascular reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,82,Female,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361417,9/3/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,72,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361539,8/11/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Deceased,Othernon-cardiovascularreasonThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,42,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361953,7/31/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Deceased,Othernon-cardiovascularreasonThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,86,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361969,9/11/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,92,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361973,7/31/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Deceased,Othernon-cardiovascularreasonThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,86,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361976,9/11/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,92,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22362046,7/18/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,40,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22362142,6/30/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occurred Death at Discharge Deceased,Sudden cardiacdeath The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Female,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22362388,7/17/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,75,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361603,9/11/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason New Requirement forDialysis, Cardiogenic ShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,79,Male,,1/1/2025,,E233601;E1311;E0511,F02,A24,G07001,B17,C19,D15,,0;22361654,9/11/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason New Requirement forDialysis, Cardiogenic ShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,79,Male,,1/1/2025,,E233601;E1311;E0511,F02,A24,G07001,B17,C19,D15,,0;22362296,6/30/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Pulmonary Cardiogenic ShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Female,,1/1/2025,,E233601;E0752,F02,A24,G07001,B17,C19,D15,,0;22362131,8/10/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Cardiogenic ShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Male,,1/1/2025,,E233601;E0511,F02,A24,G07001,B17,C19,D15,,0;22362138,9/16/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Cardiogenic ShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,80,Female,,1/1/2025,,E233601;E0511,F02,A24,G07001,B17,C19,D15,,0;22362208,8/4/2025,4/20/2026,1/23/2026,AGENT,Drug-eluting percutaneous transluminal coronary angioplasty catheter,Unknown,Unknown,Unknown,N/A,Unknown,P230035,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Cardiogenic Shock, Other VascularComplications Requiring TreatmentThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,80,Male,,1/1/2025,,E233601;E0511,F02,A24,G07001,B17,C19,D15,,0;22362371,9/6/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure Gastrointestinal BleedingThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,80,Male,,1/1/2025,,E0506;E0611,F02,A24,G07001,B17,C19,D15,,0;22361936,7/3/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,85,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22361952,7/3/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,85,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362181,8/12/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362151,9/1/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,64,Male,,1/1/2025,,E0602;E0611,F02,A24,G07001,B17,C19,D15,,0;22362154,9/1/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,64,Male,,1/1/2025,,E0602;E0611,F02,A24,G07001,B17,C19,D15,,0;22361583,9/19/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E0602;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22361903,9/19/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E0602;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22362091,9/19/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E0602;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22360543,8/4/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiacArrest, CardiacArrest, Cardiac Arrest, NewRequirement for DialysisThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,72,Female,,1/1/2025,,E0602;E061202;E1311,F02,A24,G07001,B17,C19,D15,,0;22362160,9/4/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22362163,9/4/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22362164,9/4/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22362370,7/21/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Hemorrhage Cardiac Arrest, Hematoma at AccessSite, New Requirement forDialysisThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,64,Female,,1/1/2025,,E0515,F02,A24,G07001,B17,C19,D15,,0;22361848,9/24/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,53,Male,,1/1/2025,,E0611,F02,A24,G07001,B17,C19,D15,,0;22361873,9/24/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,53,Male,,1/1/2025,,E0611,F02,A24,G07001,B17,C19,D15,,0;22361672,6/20/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Heart Failure, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,80,Male,,1/1/2025,,E0611;E233601,F02,A24,G07001,B17,C19,D15,,0;22362178,8/28/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,89,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362185,8/28/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,89,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362625,9/9/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas RegistryIt was reported that the following events occureed Death at Discharge Deceased,Acute myocardial infarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,70,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22360107,9/12/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22360121,9/12/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361160,9/17/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Othernon-cardiovascular reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,75,Female,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361424,9/3/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,72,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22362303,6/30/2025,4/20/2026,1/23/2026,Emerge,"Catheters, Transluminal Coronary Angioplasty, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K220629,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Pulmonary Cardiogenic ShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Female,,1/1/2025,,E233601;E0752,F02,A24,G07001,B17,C19,D15,,0;22361497,7/14/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,90,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22361511,7/14/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,90,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22361591,7/14/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,90,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22361968,7/3/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,85,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362147,9/12/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Non-cardiovascularprocedure or surgery Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,54,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362193,8/12/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362205,8/12/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362214,8/12/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362243,8/12/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362255,6/24/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Dissection Heart Failure, CardiacArrest, CardiogenicShock, Myocardial InfarctionThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,71,Male,,1/1/2025,,E0602;E0515;E0611;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22362155,9/1/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,64,Male,,1/1/2025,,E0602;E0611,F02,A24,G07001,B17,C19,D15,,0;22361819,9/3/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,85,Male,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22361835,9/3/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,85,Male,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362096,7/27/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,86,Male,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362102,8/21/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Deathduringprocedure Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,53,Female,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362108,7/27/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,86,Male,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362141,7/27/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,86,Male,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362173,7/27/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,86,Male,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362416,9/9/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,78,Male,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22361987,9/19/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E0602;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22362051,9/19/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E0602;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22362130,9/19/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E0602;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22362168,9/19/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E0602;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22362195,9/19/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiogenicShockThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E0602;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22360627,9/4/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22361090,9/4/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22361185,9/4/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22361230,9/4/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22361343,9/4/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22362166,9/4/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22361892,9/24/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,53,Male,,1/1/2025,,E0611,F02,A24,G07001,B17,C19,D15,,0;22361910,9/24/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,53,Male,,1/1/2025,,E0611,F02,A24,G07001,B17,C19,D15,,0;22361934,9/24/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,53,Male,,1/1/2025,,E0611,F02,A24,G07001,B17,C19,D15,,0;22361949,9/24/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,53,Male,,1/1/2025,,E0611,F02,A24,G07001,B17,C19,D15,,0;22360606,7/14/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Heart FailureThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Female,,1/1/2025,,E0611;E0511,F02,A24,G07001,B17,C19,D15,,0;22360641,7/14/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Heart FailureThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Female,,1/1/2025,,E0611;E0511,F02,A24,G07001,B17,C19,D15,,0;22360707,7/14/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Heart FailureThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Female,,1/1/2025,,E0611;E0511,F02,A24,G07001,B17,C19,D15,,0;22361644,7/20/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Heart FailureThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,82,Male,,1/1/2025,,E0611;E0511,F02,A24,G07001,B17,C19,D15,,0;22361692,7/20/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Heart FailureThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,82,Male,,1/1/2025,,E0611;E0511,F02,A24,G07001,B17,C19,D15,,0;22360995,9/8/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Infection The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Male,,1/1/2025,,E1906,F02,A24,G07001,B17,C19,D15,,0;22361014,9/8/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Infection The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Male,,1/1/2025,,E1906,F02,A24,G07001,B17,C19,D15,,0;22361024,9/8/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Infection The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Male,,1/1/2025,,E1906,F02,A24,G07001,B17,C19,D15,,0;22361045,9/8/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Infection The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Male,,1/1/2025,,E1906,F02,A24,G07001,B17,C19,D15,,0;22362304,8/26/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Ischemic StrokeThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,75,Female,,1/1/2025,,E013302;E061202,F02,A24,G07001,B17,C19,D15,,0;22362306,8/26/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Ischemic StrokeThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,75,Female,,1/1/2025,,E013302;E061202,F02,A24,G07001,B17,C19,D15,,0;22361670,9/8/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,79,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22361967,9/8/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,79,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362095,8/16/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,76,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362191,8/28/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,89,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362197,8/28/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,89,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362201,8/28/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,89,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362249,8/16/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,76,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362257,8/16/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,76,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362641,9/9/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas RegistryIt was reported that the following events occureed Death at Discharge Deceased,Acute myocardial infarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,70,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362711,9/9/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas RegistryIt was reported that the following events occureed Death at Discharge Deceased,Acute myocardial infarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,70,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362719,9/9/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas RegistryIt was reported that the following events occureed Death at Discharge Deceased,Acute myocardial infarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,70,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362730,9/9/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas RegistryIt was reported that the following events occureed Death at Discharge Deceased,Acute myocardial infarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,70,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22360133,9/12/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22360711,7/22/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Othernon-cardiovascular reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22360837,7/22/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Othernon-cardiovascular reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361184,9/17/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Othernon-cardiovascular reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,75,Female,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22362056,7/18/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,40,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22362143,6/30/2025,4/20/2026,1/23/2026,NC Emerge,"catheters, transluminal coronary angioplasty, percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K141236,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,84,Female,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361091,7/3/2025,4/20/2026,1/23/2026,ROTAPRO,"catheter, coronary, atherectomy",Unknown,Unknown,Unknown,N/A,Unknown,P900056,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,68,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362259,8/12/2025,4/20/2026,1/23/2026,SYNERGY MEGATRON,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22361274,7/3/2025,4/20/2026,1/23/2026,SYNERGY MEGATRON,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,68,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22361440,9/3/2025,4/20/2026,1/23/2026,SYNERGY MEGATRON,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,72,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22362267,8/12/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362156,9/1/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,64,Male,,1/1/2025,,E0602;E0611,F02,A24,G07001,B17,C19,D15,,0;22362140,7/18/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,76,Female,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22360552,8/4/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, CardiacArrest, CardiacArrest, Cardiac Arrest, NewRequirement for DialysisThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,72,Female,,1/1/2025,,E0602;E061202;E1311,F02,A24,G07001,B17,C19,D15,,0;22361357,9/4/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22361415,9/4/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Cardiac Arrest, Other VascularComplications RequiringTreatment, CardiacArrest, Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,63,Male,,1/1/2025,,E0602;E061202;E0511,F02,A24,G07001,B17,C19,D15,,0;22362373,7/21/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Hemorrhage Cardiac Arrest, Hematoma at AccessSite, New Requirement forDialysisThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,64,Female,,1/1/2025,,E0515,F02,A24,G07001,B17,C19,D15,,0;22362377,7/21/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Hemorrhage Cardiac Arrest, Hematoma at AccessSite, New Requirement forDialysisThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,64,Female,,1/1/2025,,E0515,F02,A24,G07001,B17,C19,D15,,0;22361058,9/8/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Infection The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Male,,1/1/2025,,E1906,F02,A24,G07001,B17,C19,D15,,0;22361421,7/1/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Ischemic StrokeThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,60,Female,,1/1/2025,,E013302;E061202,F02,A24,G07001,B17,C19,D15,,0;22361460,7/1/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Ischemic StrokeThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,60,Female,,1/1/2025,,E013302;E061202,F02,A24,G07001,B17,C19,D15,,0;22362749,9/9/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,70,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22362760,9/9/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,70,Female,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22360147,9/12/2025,4/20/2026,1/23/2026,SYNERGY XD,coronary drug-eluting stent,Unknown,Unknown,Unknown,N/A,Unknown,P150003,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;22361962,9/24/2025,4/20/2026,1/23/2026,Trapper Exchange Device,"Catheter, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K162253,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Cause of Death:Heart failure The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,53,Male,,1/1/2025,,E0611,F02,A24,G07001,B17,C19,D15,,0;22362378,9/2/2025,4/20/2026,1/23/2026,Trapper Exchange Device,"Catheter, Percutaneous",Unknown,Unknown,Unknown,N/A,Unknown,K162253,1/23/2026,D,"Agent Pas RegistryIt was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Hematoma at Access SiteThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,82,Male,,1/1/2025,,E0505;E0511,F02,A24,G07001,B17,C19,D15,,0;22361291,6/29/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Gastrointestinal Other Vascular Complications RequiringTreatmentThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,73,Female,,1/1/2025,,E0506;E0511,F02,A24,G07001,B17,C19,D15,,0;22361604,7/14/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Sudden cardiacdeath Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,90,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362148,9/12/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Non-cardiovascularprocedure or surgery Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,54,Male,,1/1/2025,,E0602,F02,A24,G07001,B17,C19,D15,,0;22362262,6/24/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Dissection Heart Failure, CardiacArrest, CardiogenicShock, Myocardial InfarctionThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,71,Male,,1/1/2025,,E0602;E0515;E0611;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22362266,6/24/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Dissection Heart Failure, CardiacArrest, CardiogenicShock, Myocardial InfarctionThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,71,Male,,1/1/2025,,E0602;E0515;E0611;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22362272,6/24/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction Dissection Heart Failure, CardiacArrest, CardiogenicShock, Myocardial InfarctionThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,71,Male,,1/1/2025,,E0602;E0515;E0611;E061202;E233601,F02,A24,G07001,B17,C19,D15,,0;22362528,8/30/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Ischemic Stroke, CardiacArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,79,Male,,1/1/2025,,E0602;E013302;E0511,F02,A24,G07001,B17,C19,D15,,0;22362115,8/21/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Deathduringprocedure Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,53,Female,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22362122,8/21/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"""Agent Pas Registry It was reported that the following events occureed Deathduringprocedure Deceased,Acute myocardialinfarction Cardiac ArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.""",,,53,Female,,1/1/2025,,E0602;E061202,F02,A24,G07001,B17,C19,D15,,0;22361932,9/18/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Othernon-cardiovascular reason Cardiogenic Shock, CardiacArrestThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,80,Male,,1/1/2025,,E0602;E233601,F02,A24,G07001,B17,C19,D15,,0;22360758,7/14/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Heart FailureThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,88,Female,,1/1/2025,,E0611;E0511,F02,A24,G07001,B17,C19,D15,,0;22362439,9/2/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas RegistryIt was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason Hematoma at Access SiteThe following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,82,Male,,1/1/2025,,E0505;E0511,F02,A24,G07001,B17,C19,D15,,0;22361071,9/8/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Infection The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,84,Male,,1/1/2025,,E1906,F02,A24,G07001,B17,C19,D15,,0;22362037,9/8/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,Acute myocardialinfarction The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,79,Male,,1/1/2025,,E061202,F02,A24,G07001,B17,C19,D15,,0;22361448,9/3/2025,4/20/2026,1/23/2026,Wolverine Coronary Cutting Balloon,"catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring",Unknown,Unknown,Unknown,N/A,Unknown,P950020,1/23/2026,D,"Agent Pas Registry It was reported that the following events occureed Death at Discharge Deceased,OtherCardiovascular Reason The following event, based on data from the CathPCI Registry, is being reported as a possible duplicate of an event that was already known to BSC and reported as an MDR when the event occurred. BSC reports the events in compliance to 21 CFR 803.3. Because CathPCI Registry data is de-identified before being transmitted to BSC, there are significant limitations to BSC's ability to correlate the data to information previously reported to BSC. Initial Reporter is not provided due to the terms of the CathPCI Registry.",,,72,Male,,1/1/2025,,E2403,F02,A24,G07001,B17,C19,D15,,0;

Description of Event or Problem · 0

THIS REPORT SUMMARIZES 203 DEATH EVENTS. IT SHOULD BE NOTED THAT SOME PATIENTS WITHIN THIS POPULATION UTILIZED MULTIPLE DEVICES. A SUMMARY OF THE TYPE AND COUNT OF ADVERSE EVENTS INCLUDE: 34 WERE PERFORATION OF VESSELS. 33 WERE HEART FAILURE/CONGESTIVE HEART FAILURE. 89 MYOCARDIAL INFARCTION. 26 CARDIOGENIC SHOCK. 4 HEMORRHAGE/BLOOD LOSS/BLEEDING. 90 CARDIAC ARREST. 5 UNSPECIFIED KIDNEY OR URINARY PROBLEM. 7 UNSPECIFIED INFECTION. 2 UNSPECIFIED RESPIRATORY PROBLEM. 3 HEMATOMA. 10 VASCULAR DISSECTION. 8 ISCHEMIA STROKE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR DEVICES REPORTED IN THE ACC CATHPCI REGISTRY. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE REGISTRY DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
997699	AGENT	DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER	OOB	BOSTON SCIENTIFIC CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR	Unknown

Terms

Patient problem · 13

• Cardiac Arrest
• Cardiogenic Shock
• Heart Failure/Congestive Heart Failure
• Hematoma
• Hemorrhage/Blood Loss/Bleeding
• Ischemia Stroke
• Myocardial Infarction
• No Clinical Signs, Symptoms or Conditions
• Perforation of Vessels
• Unspecified Infection
• Unspecified Kidney or Urinary Problem
• Unspecified Respiratory Problem
• Vascular Dissection

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Source type · 1

• Other

Type of report · 1

• Initial submission