BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOL PATH 7F, 1304-CP-7-25-L-AB (USA)

    MDR report key: 2104025 · Received May 17, 2011

    Report

    Report Number
    2030404-2011-00135
    Event Type
    Death
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT DIED 48 HOURS FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE. WHILE PERFORMING THE ABLATION USING A COOL PATH DUO CATHETER, A T9 GENERATOR AND A COOL POINT PUMP, A BLOOD PRESSURE DROP WAS NOTED, FOLLOWED BY VISUALIZATION OF A PERICARDIAL EFFUSION ON INTRACARDIAC ECHOCARDIOGRAPHY. A PERICARDIOCENTESIS WAS PERFORMED BUT THE PATIENT REMAINED UNSTABLE. OPEN HEART SURGERY WAS PERFORMED AND A HOLE IN THE LEFT ATRIAL LATERAL WALL WAS CLOSED. THE PATIENT REPORTEDLY DIED APPROXIMATELY 48 HOURS FOLLOWING THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F, 1304-CP-7-25-L-AB (USA) CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 84309 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death