BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR DEVICES

    MDR report key: 437653 · Received January 13, 2003

    Report

    Report Number
    437653
    Event Type
    Malfunction
    Date Received
    January 13, 2003
    Date of Event
    December 12, 2002
    Report Date
    January 9, 2003
    Manufacturer
    PERCLOSE
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ARTERIAL CLOSURE, THE PERCLOSE CLOSURE DEVICE FAILED CAUSING A PSEUDOANEURYSM. PATIENT ADMITTED TO SCU WHERE PRESSURE WAS HELD FOR A PERIOD OF TIME. PATIENT DISCHARGED WITH NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR DEVICES PERCLOSE CLOSURE MGB PERCLOSE * 88021-614

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other