BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 3876186 · Received June 4, 2014

    Report

    Report Number
    3876186
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE WIRE DID NOT COME OUT WHEN FIRED. THE DEVICE WAS BEING TESTED PRIOR TO USE ON THE PATIENT AND MALFUNCTIONED. THE DEVICE WAS REMOVED AND SENT TO THE COMPANY FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325675 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. * 30924K1

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR