BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE

    MDR report key: 1031088 · Received March 28, 2008

    Report

    Report Number
    1031088
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER STARCLOSE DEPLOYMENT, THE DELIVERY DEVICE WOULD NOT RELEASE FROM THE CLIP. MULTIPLE ATTEMPTS TO RELEASE THE DELIVERY DEVICE WERE UNSUCCESSFUL. A CALL WAS PLACED TO THE PRODUCT REP FOR TROUBLESHOOTING, WHO RECOMMENDED PULLING WITH FIVE POUNDS OF FORCE. THE DEVICE EVENTUALLY RELEASED WITH FORCE WELL IN EXCESS OF FIVE POUNDS. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR DEVICES M13614677010D 61113-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR