BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR DEVICE

    MDR report key: 433398 · Received December 13, 2002

    Report

    Report Number
    MW1026995
    Event Type
    Injury
    Date Received
    December 13, 2002
    Date of Event
    November 12, 2002
    Report Date
    November 21, 2002
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CARDIAC CATHETERIZATION PROCEDURE ENDED WITH DEPLOYMENT OF PERCLOSE VASCULAR CLOSURE DEVICE. DEVICE REMAINED DEPLOYED IN RIGHT FEMORAL ARTERY AND PHYSICIAN WAS UNABLE TO WITHDRAW IT. THIS REQUIRED SURGICAL REMOVAL OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR DEVICE 6-FR PERCLOSE SUTURE MEDICATED CLOSURE DEVICE MGB ABBOTT VASCULAR * CE0050

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R