BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR CLOSURE DEVICE

    MDR report key: 6587093 · Received May 22, 2017

    Report

    Report Number
    MW5069986
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    May 19, 2017
    Report Date
    May 22, 2017
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ABBOTT VASCULAR CLOSURE DEVICE (STARCLOSE LOT # 7030241) DID NOT DEPLOY CORRECTLY WHEN USED BY THE ATTENDING MD. DESCRIBED AS THE SHEATH NOT SPLITTING AS IT SHOULD. NO VASCULAR CLOSE DEVICE WAS IMPLANTED AND MANUAL PRESSURE WAS HELD BY THE ATTENDING. THE PT WAS BEING ADMITTED BUT WAS NOT ANTICOAGULATED WITH TPA AND REOPRO, SO ADD'L MONITORING FOR BLEEDING WAS REQUIRED ON ADMISSION SINCE NO VASCULAR CLOSURE DEVICE COULD BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362035 ABBOTT VASCULAR CLOSURE DEVICE STARCLOSE MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other