BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL EVOLUTION

    MDR report key: 3181432 · Received May 23, 2013

    Report

    Report Number
    3181432
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    ANGIOSEAL FAILURE (ST. JUDE MEDICAL) - FAILURE OF DELIVERY DEVICE (SEALANT) TO SEAT IN SHEATH END FOR PROPER DEPLOYMENT.EXCHANGED DEFECTIVE DEVICE FOR A WORKING DEVICE.STAFF TOOK APPROPRIATE ACTION TO REMOVE PRODUCT WITH SAME LOT NUMBER FROM INVENTORY. VENDOR CONTACTED IMMEDIATELY POST PROCEDURE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230037 ANGIO-SEAL EVOLUTION DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL C610134 3874797

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR