BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 3893803 · Received June 19, 2014

    Report

    Report Number
    MW5036781
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ABBOTT VASCULAR INC
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS DEPLOYING PERCLOSE PROGLIDE DEVICE IN PATIENT'S RIGHT GROIN. ONE OF THE SUTURES DIDN'T COME OUT DURING DEPLOYMENT. DEVICE REMOVED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361795 PERCLOSE PROGLIDE PERCLOSE PROGLIDE MGB ABBOTT VASCULAR INC 12233663

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other