BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT PERCLOSE PROSTYLE

    MDR report key: 21298041 · Received January 31, 2025

    Report

    Report Number
    MW5165591
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 23, 2025
    Report Date
    January 29, 2025
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PERCLOSE DEVICE FAILURE AFTER SHEATH REMOVAL. PATIENT'S RIGHT GROIN HAD TO BE MANUALLY HELD FOR 30MINS AND FEMSTOP APPLIED. 3 OTHER PERCLOSE DEVICES WERE SUCCESSFULLY USED AFTERWARDS. WE WERE UNABLE TO DETERMINE WHICH OF THE 4 PERCLOSE DEVICES FAILED: LOT: 12773-03, REF: 4101743, LOT: 12773-03, REF: 4110141, LOT: 12773-03, REF: 4110141, LOT: 12773-03, REF: 4110141.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246126 ABBOTT PERCLOSE PROSTYLE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male