BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAR CLOSE SE DEVICE

    MDR report key: 1522307 · Received November 2, 2009

    Report

    Report Number
    MW5013323
    Event Type
    Other
    Date Received
    November 2, 2009
    Date of Event
    October 9, 2009
    Report Date
    November 2, 2009
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A MALE PT HAVING CARDIAC CATHETERIZATION WITH STAR CLOSURE DEVICE PER A DR. DEVICE WAS DEPLOYED TOO EARLY CAUSING THE SHEATH TO KINK AND THEREFORE, IT STARTED TO SHRED. MANUAL PRESSURE WAS HELD, PATIENT DID DEVELOP A HEMATOMA BUT NO OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAR CLOSE SE DEVICE NONE MGB ABBOTT VASCULAR 6FR 800486H

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR