BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 3865528 · Received June 3, 2014

    Report

    Report Number
    3865528
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ABBOTT VASCULAR, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS USING A PERCLOSE PROGLIDE DEVICE DURING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR. AS HE WAS PULLING STRINGS TO CLOSE PERCUTANEOUS HOLE, STRINGS PULLED OUT WITHOUT ANY TENSION. THE DOCTOR STATES THAT THE ARTERY THEN TORE AND FEELS THAT THE DEVICE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324713 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR, INC. * 40311K1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR