BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRK-1 XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

    MDR report key: 11667833 · Received April 14, 2021

    Report

    Report Number
    3008452825-2021-00191
    Event Type
    Death
    Date Received
    April 14, 2021
    Date of Event
    January 3, 2021
    Report Date
    April 14, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRC
    PMA / PMN Number
    K122587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBERS: 3008452825-2021-00190, 3005334138-2021-00210, 3005334138-2021-00211, 3005334138-2021-00212. THIRTEEN DAYS FOLLOWING THE ABLATION PROCEDURE, THE PATIENT EXPERIENCED A STROKE FOLLOWED BY CARDIAC ARREST IN THE ICU AND PASSED AWAY ON (B)(6) 2021. IT WAS NOTED THE PATIENT HAD A FAMILY HISTORY OF CVAS. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED TO RULE OUT THROMBOSIS PRIOR TO PROCEDURE. NO ACT WAS DONE, HOWEVER 7500 UI OF HEPARIN WERE GIVEN TO THE PATIENT DURING THE PROCEDURE. PATIENT WAS STARTED ON ANTICOAGULANT POST PROCEDURE. FURTHER INFORMATION REGARDING THIS EVENT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562900 BRK-1 XS TRANSSEPTAL NEEDLE, 71 CM LENGTH TROCAR DRC ST. JUDE MEDICAL G407209

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death