BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE 6F

    MDR report key: 4100692 · Received July 24, 2014

    Report

    Report Number
    4100692
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    VASCULAR CLOSURE DEVICE DID NOT DEPLOY IN THE FEMORAL ARTERY. THE ACTUAL STAR-CLIP CAME OUT WITH THE DEVICE AND NOTHING WAS IMPLANTED INTO THE PATIENT. MANUAL PRESSURE WAS HELD UNTIL HEMOSTASIS ACHIEVED. NO OTHER ISSUES WERE ENCOUNTEREDPATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433632 STARCLOSE SE 6F DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR * 40221K1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR