BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR "STARCLOSE"

    MDR report key: 911471 · Received September 11, 2007

    Report

    Report Number
    MW5003728
    Event Type
    Malfunction
    Date Received
    September 11, 2007
    Date of Event
    September 10, 2007
    Report Date
    September 11, 2007
    Manufacturer
    ABBOTT VASCULAR INC
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "STARCLOSE" WOULD NOT DEPLOY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR "STARCLOSE" VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR INC 56086-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other