BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE

    MDR report key: 493847 · Received October 31, 2003

    Report

    Report Number
    MW1030022
    Event Type
    Injury
    Date Received
    October 31, 2003
    Date of Event
    October 17, 2003
    Report Date
    October 20, 2003
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERCLOSE DEVICE DEPLOYED BY MD. IT WAS NOTED THAT DEVICE SEPARATED AT THE UNION OF THE HOLLOW METAL TUBE AND THE PLASTIC CATHETER. THE PLASTIC CATHETER WAS KINKED INSIDE ARTERY. THERE WAS HEMOSTASIS AT SITE AND DISTAL FLOW WAS NOT COMPROMISED BUT CATHETER DID HAVE TO BE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE VASCULAR CLOSURE DEVICE MGB ABBOTT VASCULAR DEVICES * 7089-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization