BEUDAMED
    FDA Adverse Event Death Summary report: N

    IABP

    MDR report key: 28895 · Received November 27, 1995

    Report

    Report Number
    28895
    Event Type
    Death
    Date Received
    November 27, 1995
    Date of Event
    November 19, 1995
    Report Date
    November 22, 1995
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ON IABP AND IT RUPTURED. NEW SHEATH WOULD NOT ADVANCE INTO THE FEMORAL ARTERY OVER THE GIDE WIRE. LEFT GROIN AREA WAS EXPLORED AND FEMORAL ARTERY HAD TORN WHEN IABP WAS D/C ED. CLAMP APPLIED TO CONTROL BLEEDING. PT DEVELOPED BRADYCARDIA AND THEN ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IABP Implant IABP DSP ST. JUDE MEDICAL, INC. FF5286 506084

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death