BEUDAMED
    FDA Adverse Event Death Summary report: N

    QDOT MICRO

    MDR report key: 23888774 · Received December 24, 2025

    Report

    Report Number
    2029046-2025-04294
    Event Type
    Death
    Date Received
    December 24, 2025
    Date of Event
    November 28, 2025
    Report Date
    March 19, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INTERNAL REVIEW OF THE EVENT, THE DEATH CANNOT BE COMPLETELY DISSOCIATED FROM BOTH THE QDOT MICRO CATHETER AND THE VARIPULSE¿ BI-DIRECTIONAL CATHETERS AS ABLATION HAD OCCURRED DURING THE PROCEDURE WITHIN THE PULMONARY/VEINS AND THE CTI LINE. CORRECTION TO FOLLOW UP REPORT (B)(4): THE H6. HEALTH EFFECT - CLINICAL CODE, H6. MEDICAL DEVICE PROBLEM CODE AND H6. HEALTH EFFECT - IMPACT CODE HAVE BEEN UPDATED. THE FOLLOWING CODES WERE ADDED TO THE QDOT MICRO SUSPECT MEDICAL DEVICE: CARDIAC ARREST (E0602), CARDIAC TAMPONADE (E0605), HEMORRHAGE/BLEEDING (E0506), DEATH (F02), SURGICAL INTERVENTION (F19), ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM (A24). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 19 DEC 2025. IT WAS INDICATED THAT THE FLOW RATE WAS 30ML/MIN. THE ABLATION LOCATIONS WERE LEFT SUPERIOR PULMONARY VEIN (LSPV), LEFT INFERIOR PULMONARY VEIN (LIPV), RIGHT SUPERIOR PULMONARY VEIN (RSPV), RIGHT INFERIOR PULMONARY VEIN (RIPV), AND EUSTACHIAN RIDGE (CTI), WITH BOTH VARIPULSE¿ AND QDOT. THE ARRHYTHMIA TREATED WAS PAROXYSMAL ATRIAL FIBRILLATION (PAF). THE PRESENTING RHYTHM WAS NORMAL SINUS RHYTHM (NSR), AND RHYTHM DURING ABLATION WAS NSR. NO CARDIOVERSION PRIOR TO ABLATION. THE NUMBER OF PULSED FIELD ABLATION (PFA) APPLICATIONS WAS 67 (61 IN LEFT ATRUM (LA)). THE NUMBER OF PFA ABLATIONS WAS 23 (21 IN LA). THE NUMBER OF RADIOFREQUENCY (RF) ABLATIONS WAS 26 (ALL CTI). THERE WERE NO ANTERIOR PULMONARY VEIN (PV) LESION SETS THAT COULD HAVE ABLATED THE LEFT ATRIAL APPENDAGE (LAA). THE ACTIVATED CLOTTING TIME (ACT) WAS ALWAYS ABOVE 350 WHEN ABLATING WITH VARIPULSE¿ . THE SHEATH AND CATHETERS EXCHANGES WERE VIZIGO SHEATH TO OCTARAY IN LA. THE AVERAGE IMPEDANCE WAS RF: 108.0, PF (LA): 151.5, AND PF (CTI): 135.4. THE PUMP MODE WAS MANUAL. PRE-ABLATION THROMBUS CHECKS WERE PERFORMED WITH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). PROTAMINE MANAGEMENT WAS STANDARD OF CARE FOR PERICARDIOCENTESIS. THERE WAS NO PATIENT ANATOMICAL ABNORMALITIES. THE ANTICOAGULATION STRATEGY USED WAS XARELTO, HEPARINIZED SALINE TARGETING ACT 350. THE PRESUMED ROOT CAUSE WAS RF DURING CTI CAUSED SLOW EFFUSION, WHICH WAS TREATED POST-PROCEDURE WITH PERICARDIOCENTESIS. POST-PROCEDURE PULMONARY HEMORRHAGE WAS NOTED WITH UNKNOWN ETIOLOGY. CLIFF NOTES ARE A CTI LINE WAS PERFORMED WITH RF. NO BLOCK ACHIEVED, SO THEY USED VARIPULSE¿ TO GET BLOCK ON CTI. A SMALL EFFUSION WAS NOTED AFTER CTI LINE WITH RF. THEY THEN PROCEEDED TO THE LEFT SIDE AND DID PULMONARY VEIN ISOLATION (PVI) WITH VARIPULSE¿ CATHETER. NO ISSUES. EFFUSION WAS CHECKED AT THE END AND IT WAS SLIGHTLY WORSENING. A TAP WAS PERFORMED TAKING OFF 200CC OF FLUID. THE PATIENT WAS STABLE AND SENT TO RECOVERY. IN THE MIDDLE OF THE NIGHT, A TAMPONADE OCCURRED AND CPR WAS PERFORMED. THEY WERE UNABLE TO RESCUE THE PATIENT. AUTOPSY NOTED A TEAR OR HEMORRHAGE IN THE PULMONARY VEINS LIKELY FROM AGGRESSIVE CPR, AND IT WAS SUGGESTED THAT THE RF ARM OF CTI CAUSED A SLOW EFFUSION. THE INFORMATION RECEIVED ON 06-JAN-2026 INDICATED THAT THE EFFUSION WAS NOTED POST CTI LINE WITH RF/QDOT. HOWEVER, EFFUSION WAS DEEMED MINIMAL AND CASE PROCEEDED TO THE LEFT ATRIUM FOR THE PVI PORTION OF THE CASE WITH VARIPULSE¿. AFTER AN UNREMARKABLE PVI USING VARIPULSE¿, THE EFFUSION WAS LARGER, AND THE DECISION WAS MADE TO TAP FOR 230CC'S. THE PATIENT WAS STABLE WHEN THEY LEFT, AND EFFUSION WAS UNDER CONTROL. IN THE NIGHT, THE PATIENT BECAME COMPROMISED WITH PULSELESS ELECTRICAL ACTIVITY AND CPR WAS ADMINISTERED. THE AUTOPSY DEMONSTRATED DAMAGE TO ONE OF THE PULMONARY VEINS, AND IT WAS PRESUMED THAT THE DAMAGE CAME FROM AGGRESSIVE CPR. HOWEVER, IT WAS NOT KNOWN WHY THE PATIENT'S CONDITION BECAME WORSE AFTER CONTROLLING THE BLEED FROM THE INITIAL EFFUSION FROM THE CTI WITH RF. THE INFORMATION RECEIVED ON 09-JAN-2026 INDICATED THAT THE VARIPULSE¿ WAS NOT USED FOR ABLATION AT THE CTI. IT WAS ALSO INDICATED THAT THE INITIAL ADVERSE EVENT, AN EFFUSION, WAS OBSERVED WITH ICE, DURING THE CTI LINE, WHEN IT WAS ABLATED WITH A QDOT CATHETER, PRIOR TO THE VARIPULSE¿ BEING USED AT ALL. THE PHYSICIAN PROCEEDED TO THE LA ABLATION WITH VARIPULSE¿, AFTER WHICH THEY APPLIED TOUCH UP PFA ON THE POSTERIOR CTI LINE. BASED ON THE INFORMATION PROVIDED, THERE WAS NO DEVICE MALFUNCTION REPORTED DURING THE PROCEDURE THAT CONTRIBUTED TO THE PATIENT¿S DEATH. HOWEVER, THE DEATH CANNOT BE COMPLETELY DISSOCIATED FROM THE VARIPULSE¿ ABLATION CATHETER AS ABLATION HAD OCCURRED DURING THE PROCEDURE WITHIN THE PULMONARY VEINS. CORRECTION TO THE INITIAL MW REPORT: THE H6. HEALTH EFFECT - CLINICAL CODE, H6. MEDICAL DEVICE PROBLEM CODE AND H6. HEALTH EFFECT - IMPACT CODE HAVE BEEN UPDATED THE FOLLOWING CODES WERE REMOVED FROM THE QDOT MICRO SUSPECT MEDICAL DEVICE: HEMORRHAGE/BLEEDING (E0506), DEATH (F02), SURGICAL INTERVENTION (F19), ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM (A24). THESE CODES WERE APPLIED TO ANOTHER SUSPECT MEDICAL DEVICE, WHICH IS THE VARIPULSE¿ BI-DIRECTIONAL CATHETER. SEE MANUFACTURER REPORT NUMBER 2029046-2026-00193. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ¿ PAROXYSMAL ABLATION PROCEDURE WITH A QDOT CATHETER, THE PATIENT EXPERIENCED A SMALL" PERICARDIAL EFFUSION (PE) THAT WAS TREATED WITH PERICARDIOCENTESIS, REQUIRED CARDIOPULMONARY RESUSCITATION (CPR), AND SUBSEQUENTLY WAS GIVEN MANY UNITS OF BLOOD, AND FINALLY WAS FOUND TO HAVE A PULMONARY HEMORRHAGE AND EXPIRED. IT WAS REPORTED "THAT" THE PATIENT HAD A "SMALL" PERICARDIAL EFFUSION. THE EFFUSION WAS NOTICED "VERY EARLY ON" AND WAS OBSERVED TO NOT REALLY BE CHANGING OVER THE COURSE OF THE PROCEDURE BUT WAS OBSERVED TO GROW SHORTLY AFTER THE PROCEDURE. IT WAS OBSERVED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND WITHOUT ANY OTHER SYMPTOMS. THEY CONFIRMED THE PERICARDIAL EFFUSION WITH A TRANSTHORACIC ECHO. THE PERICARDIOCENTESIS WAS PERFORMED AND THEY DRAINED 230ML OF BLOOD. THE LAST KNOWN STATUS OF THE PATIENT WAS STABLE AND IN RECOVERY. THE BIOSENSE WEBSTER (BWI) PRODUCTS IN THE BODY AT THE TIME OF THE EVENT WERE A BRAND NEW SOUNDSTAR CATHETER, WEBSTER CS CATHETER, VIZIGO SHEATH, AND A QDOT MICRO CATHETER. THEY DID NOT HAVE THE CATALOG OR LOT INFORMATION FOR ANY OF THE CATHETERS OR THE SHEATH, AND THEY HAVE ALL BEEN DISCARDED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED. OTHER DEVICES USED WERE CARTO 3 SYSTEM AND NGEN RF GENERATOR. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PATIENT HAD EXPIRED. THE DATE OF DEATH REPORTED WAS (B)(6) 2025. THE REPORTER ADDED THAT THE CAUSE OF DEATH IS NOT CLEAR. AFTER THE FIRST CALL WAS COMPLETED, THE PATIENT HAD A PULMONARY HEMORRHAGE, AND PRIOR TO THAT, CPR HAD BEEN PERFORMED ON THE PATIENT. THIS HAPPENED AFTER THE PERICARDIOCENTESIS AND AFTER THE PATIENT HAD STABILIZED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT (AE) WAS THAT THE EXACT CAUSE OF THE AE IS UNKNOWN. IN PHYSICIAN¿S OPINION, THE CAUSE OF DEATH IS PULMONARY HEMORRHAGE, THE CAUSE OF WHICH IS NOT CLEAR. THE PATIENT WAS OBSERVED TO HAVE A SMALL PERICARDIAL EFFUSION WHICH WAS TREATED WITH PERICARDIOCENTESIS IN THE LAB. THE PATIENT LEFT THE LAB IN STABLE CONDITION. HOURS LATER, PATIENT REQUIRED CPR, AND SUBSEQUENTLY WAS GIVEN MANY UNITS OF BLOOD, AND FINALLY WAS FOUND TO HAVE A PULMONARY HEMORRHAGE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH BAYLIS NEEDLE. PRIOR TO NOTING THE PE, ABLATION WAS PERFORMED, AND SMALL EFFUSION WAS NOTED ON ICE DURING INITIAL ABLATION ON CAVOTRICUSPID ISTHMUS (CTI), PRIOR TO TRANSEPTAL. THERE WAS NO EVIDENCE OF STEAM POP. IT WAS NOT CLEAR WHEN EXACTLY THE INJURY OCCURRED. THE FLOW SETTING WAS QDOT STANDARD SETTINGS (4ML AND 15ML). THE PATIENT REQUIRED CARDIAC SURGERY FOLLOWING CPR DESCRIBED ABOVE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. THERE WERE NO ERROR MESSAGES OBSERVED ON BWI EQUIPMENT DURING THE PROCEDURE. THE FORCE VISUALIZATION FEATURES USED WERE VECTOR, DASHBOARD, AND VISITAG. THE VISITAG MODULE PARAMETERS FOR STABILITY USED WERE STABILITY+, 3SEC, 25% >=3G AND 2MM TAGS. THERE WAS NO ADDITIONAL FILTER USED WITH THE VISITAG. THE COLOR OPTION PROSPECTIVELY USED WAS IMPEDANCE DROP. A TRUPULSE GENERATOR WAS ALSO USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381152 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death| L| R BAYLISS NEEDLE.| CARTO 3 SYSTEM.| TRUPULSE GENERATOR, US.| UNK_CARTO VIZIGO SHEATH.| UNK_NGEN RF GENERATOR.| UNK_SOUNDSTAR.| UNK_VISITAG SURPOINT¿ EPU.| UNK_WEBSTER CS WITH AUTO ID.