BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE

    MDR report key: 758054 · Received June 19, 2006

    Report

    Report Number
    MW1040326
    Event Type
    Other
    Date Received
    June 19, 2006
    Date of Event
    June 15, 2006
    Report Date
    June 19, 2006
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD AN UNEVENTFUL DIAGNOSTIC CARDIAC CATHETERIZATION WITH A SUCCESSFUL FEMORAL ARTERY CLOSURE WITH A STARCLOSE DEVICE. THE PATIENT RETURNED 2 WEEKS LATER WITH A COMPLAINT OF GROIN PAIN. ON EXAMINATION, THE STARCLOSE WAS FOUND TO HAVE LOOSENED FROM THE ARTERY AND WAS MIGRATING UP THROUGH THE SKIN. THE SURROUNDING SCAR TISSUE UNDER THE SKIN WAS DISSECTED AND THE STARCLOSE WAS REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other