BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE

    MDR report key: 17389526 · Received July 21, 2023

    Report

    Report Number
    MW5119992
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    July 18, 2023
    Report Date
    July 20, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE CLOSING THE FEMORAL ARTERY ACCESS SITE POST PROCEDURE, THE PERCLOSE PROSTYLE DEVICE FAILED. STEPS WERE TAKEN AND AN ANGIOSEAL CLOSURE DEVICE WAS UTILIZED AND SUCCESSFUL HEMOSTASIS WAS ACHIEVED. PERCLOSE PROSTYLE, LOT: 3051942, REF: 12773-03, EXP: 2025-04-30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773524 PERCLOSE PROSTYLE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 3051942

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention