BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR DEVICES

    MDR report key: 548030 · Received September 21, 2004

    Report

    Report Number
    MW4003780
    Event Type
    Malfunction
    Date Received
    September 21, 2004
    Date of Event
    August 6, 2004
    Report Date
    August 25, 2004
    Manufacturer
    ABBOTT LAB
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPT TO DEPLOY 8F PERCLOSE FAILED AS ITS SUTURES WERE ALREADY CUT AT THE TIME ITS FOOT WAS REMOVED. SO THE CFA WAS REWIRED THROUGH THE SIDE PORT OF THE PERCLOSE AND AN 8F WAS SUCCESSFULLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR DEVICES PERCLOSE PROGLIDE MGB ABBOTT LAB 12673 18092-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR