BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAQUET - AXILLO-BIFEMORAL HEMOGARD KNITTED

    MDR report key: 17490568 · Received August 9, 2023

    Report

    Report Number
    MW5122781
    Event Type
    Death
    Date Received
    August 9, 2023
    Date of Event
    July 21, 2023
    Report Date
    August 7, 2023
    Manufacturer
    MAQUET" GENTINGE GROUP / INTERVASCULAR, SAS
    Product Code
    MAL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNDERWENT HEART CAUTERIZATION FOR POSSIBLE INTERVENTION AND INSERTION OF IMPELLA AND ECMO DUE TO CARDIOGENIC SHOCK. DURING INSERTION OF BIFEMORAL GRAPH VIA CUTDOWN TO LEFT ARTERY, UNCONTROLLED BLEEDING. BLEEDING AT GRAPH SITE DESCRIBED AS "SPRAYING/ APPEARING AS A SPRINKLER". ESTIMATED BLOOD LOSS >4L. UNABLE TO CONTROL BLEEDING, PATIENT EXPIRED. THERAPEUTIC RANGE FOR HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014057 MAQUET - AXILLO-BIFEMORAL HEMOGARD KNITTED GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE MAL MAQUET" GENTINGE GROUP / INTERVASCULAR, SAS WATER PERM <5ML/CM2/MIN 22K06

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Death