GUIDESTAR STEERABLE GUIDING SHEATH
Report
- Report Number
- 1035166-2024-00132
- Event Type
- Death
- Date Received
- November 22, 2024
- Date of Event
- July 5, 2024
- Report Date
- January 3, 2025
- Manufacturer
- OSCOR INC.
- Product Code
- DYB
- UDI-DI
- 00885672010911
- PMA / PMN Number
- K140406
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
SUBMISSION IS BEING REPORTED FOR ADMINISTRATIVE PURPOSES DUE TO PATIENT DEATH, WITHOUT AN IDENTIFIED DEVICE OR USE PROBLEM. THERE WAS NO REPORTED DEVICE MALFUNCTION. THE EVENT IS RELATED TO THE PATIENT'S HEALTH. THE ABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS DISCHARGED AFTER PROCEDURE, AND PATIENT'S HEALTH STATUS WAS NORMAL. THE DAY AFTER PROCEDURE, THE CLINICAL SITE REPORTED THAT THE PATIENT WAS DECEASED. AUTOPSY WAS CONDUCTED AND CONCLUDED THAT THE CAUSE OF DEATH WAS A [?]HEART ATTACK'. PATIENT DEATH WAS ON (B)(6) 2024. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
NO PRODUCT WAS PROVIDED FOR ANALYSIS. THERE WAS NO ADVERSE EVENT WITH THE PATIENT REPORTED. REVIEW IS NOT POSSIBLE AS LOT NUMBER IS UNKNOWN. THE LACK OF LOT TRACEABILITY PREVENTS PERFORMING A DEVICE HISTORY RECORDS REVIEW FOR ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES THE PRODUCTION OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A CAPA WAS OPENED TO INVESTIGATE THIS ISSUE. NO FURTHER CORRECTIVE ACTIONS REQUIRED. NO DEVICE WAS RETURNED FOR ANALYSIS, AND THE LOT NUMBER IS UNKNOWN. THE DEVICE HISTORY REVIEW WAS NOT PERFORMED, AS THE LOT NUMBER IS UNKNOWN. HOWEVER, INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT PASS ALL IN-PROCESS AND QA FINAL INSPECTIONS BEFORE SHIPPING TO THE CUSTOMER. THIS COMPLAINT IS NON-VERIFIABLE. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
SERIOUSNESS CRITERIA. DEATH: YES. LIFE-THREATENING ILLNESS OR INJURY: NO. A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: YES ADMISSION DATE: (B)(6) 2024 DISCHARGE DATE: (B)(6) 2024 MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION: NO CHRONIC DISEASE: NO FETAL DISTRESS, FETAL DEATH, A CONGENITAL ABNORMALITY, OR BIRTH DEFECT INCLUDING PHYSICAL OR MENTAL IMPAIRMENT: NO. 04/NOV/2024 ADDITIONAL INFORMATION: PATIENT (B)(6) WAS TREATED BY ABLATION PROCEDURE ON (B)(6) 2024, THERE WAS NO DELAY IN PROCEDURE, AND NO ADDITIONAL MEDICAL INTERVENTION DURING PROCEDURE WAS NOTED. PATIENT WAS DISCHARGED AFTER PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT'S HEALTH STATUS WAS NORMAL. THE INVESTIGATIONAL DEVICES (CABLE, CATHETER, GENERATOR, AND SHEATH) WERE USED ONLY ONCE. IN ADDITION TO THE INVESTIGATIONAL CATHETER, A MAPPING CATHETER WAS ALSO USED. THE DEVICE WAS USED AS PER PROTOCOL, AND NO DEVICE DEFICIENCY WAS REPORTED. AFTER NORMAL USE, SINCE THERE WAS NO DEVICE DEFICIENCY REPORTED, THE SHEATH WAS DESTROYED AT SITE AFTER USE. AT THE TIME OF THE DESTRUCTION, THIS EVENT WAS NOT YET KNOWN. AS THE PROCEDURE WAS SUCCESSFULLY PERFORMED THERE WAS NO NEED FOR REPLACEMENTS. ON (B)(6) 2024 THE CLINICAL SITE REPORTED THAT THE PATIENT WAS DECEASED. THIS EVENT WAS REPORTED ON THE SAME DAY AS A SERIOUS ADVERSE EVENT (SAE). AUTOPSY WAS CONDUCTED AND CONCLUDED THAT THE CAUSE OF DEATH WAS A [?]HEART ATTACK'. WHAT COULD HAVE BEEN THE CAUSE OF THE INCIDENT COULD NOT BE CONCLUDED. THE PATIENT SUFFERED A HEART-ATTACK AFTER ABLATION PROCEDURE. PATIENT WAS DIAGNOSED WITH AFIB WHICH IS A REQUIREMENT FOR INCLUSION IN THE OMNY-IRE STUDY, BUT THERE WERE NO CONFIRMED UNDERLYING ISSUES OR HEALTH CONDITIONS THAT COULD HAVE BEEN THE CAUSE OF DEATH. INVESTIGATION CONCLUDED THAT THE CAUSE OF DEATH WAS A [?]HEART ATTACK'. THE CLINICAL SITE REPORTED THAT THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE INCIDENT AND THE INVESTIGATIONAL DEVICE GUIDESTAR SHEATH. PER END USER, PATIENT'S DEATH IS NOT RELATED TO THE INVESTIGATIONAL DEVICES OR ITS COMPONENTS. PATIENT PASSED AWAY AT THE INVESTIGATOR SITE: (B)(6). 22/NOV/2024 THE DATE WHEN THE EVENT WAS REPORTED TO SPONSOR IS (B)(6) 2024, THE SAME DAY OF PATIENT'S DEATH.
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE INTRODUCER SHEATH RUBBER VALVE WAS NOT SPLITTING PROPERLY AND GETTING STUCK TO THE LEAD. MULTIPLE SHEATHS WERE ATTEMPTED, HOWEVER REGARDLESS OF SIZE THE SAME ISSUE OCCURRED. THE SHEATHS WERE ATTEMPTED, REMOVED NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. CUSTOMER REPORTED THE FOLLOWING ON (B)(6)2024: PROCEDURE COMPLETED BY USING MOSQUITO SCISSORS USED TO PULL RUBBER VALVE APART. HOSPITAL HAS REPLIED AND SAID POSSIBLY 7 SHEATHS WERE USED. CUSTOMER REPORTED THE FOLLOWING ON (B)(6)2025: THE SALES REP HAS QUERIED THE DEVICE RETURN WITH THE CUSTOMER THE REPLY IS "ASKED AND UNKNOWN" THIS IMPLIES THAT THE CUSTOMER REFUSES TO ANSWER OR REFUSES TO RETURN THE DEVISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1777633 | GUIDESTAR STEERABLE GUIDING SHEATH | INTRODUCER, CATHETER | DYB | OSCOR INC. | D-1433-01-SI | EG-09740 | 00885672010911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Death |