BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE

    MDR report key: 3804347 · Received May 7, 2014

    Report

    Report Number
    3804347
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CEREBRAL ANGIOGRAM, A STARCLOSE DEVICE WAS USED AND THE DEVICE SHEATH WOULD NOT LOCK CORRECTLY. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276658 STARCLOSE SE VASCULAR CLOSURE DEVICE MGB ABBOTT VASCULAR INC. 14679 40317K1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR