BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIO-SEAL

    MDR report key: 1202224 · Received October 15, 2008

    Report

    Report Number
    MW5008630
    Event Type
    Death
    Date Received
    October 15, 2008
    Date of Event
    August 30, 2008
    Report Date
    October 15, 2008
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WITH HISTORY OF CABG X 4 IN PAST, ADMITTED WITH CHEST PAIN, UNDERWENT CARDIAC CATH IN 2008 AND RIGHT FEMORAL APPROACH WAS USED. POST PROCEDURE ANGIO-SEAL CLOSURE DEVICE WAS USED. THE FOLLOWING DAY, THE PATIENT WAS AMBULATED AND HAD SYNCOPAL EPISODE, FOUND TO HAVE HEMATOMA AT GROIN CATH SITE. DIRECT PRESSURE HELD, MD EVAL, FELT TO HAVE TAMPONADED OFF. BLOOD PRESSURE DROPPED WITHIN 30 MINUTES, STAT CT, TO OR-FOUND CLOSURE DEVICE HAD FAILED- WAS OFF, HOLE IN ARTERY WITH ACTIVE BLEEDING, REPAIRED, ESTIMATED 2000CC BLOOD IN THIGH. PT ARRESTED IN OR, RESUSCITATED, MADE LIMITED CODE THE FOLLOWING DAY AT FAMILY REQUEST, PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL NONE MGB

    Patients

    Seq Age Sex Outcome Treatment
    1 Death