BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE

    MDR report key: 1232804 · Received November 10, 2008

    Report

    Report Number
    1232804
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 10, 2008
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    STARCLOSE DEVICE WAS BEING USED ON PATIENT POST CARDIAC CATH PROCEDURE. WHEN THE PATIENT GOT UP TO AMBULATE THE DEVICE DID NOT HOLD AND THE PATIENT HAD SLIGHT BLEEDING. A PRESSURE DEVICE WAS APPLIED AND THE PATIENT WAS PUT ON BEDREST FOR 4 HOURS. PATIENT DISCHARGED IN NORMAL TIMEFRAME. PATIENT DID NOT DEVELOP ANY OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE DEVICE MGB ABBOTT VASCULAR DEVICES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR OTHER| OTHER