BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE

    MDR report key: 2050312 · Received April 6, 2011

    Report

    Report Number
    MW5020206
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH INFECTIVE ENDOCARDITIS. HAD CORONARY AND CEREBRAL ANGIOGRAPHY. HAD RIGHT FEMORAL SHEATH CLOSED WITH STARCLOSE CLOSURE DEVICE. FEMORAL DUPLEX AFTERWARDS SHOWED DEVICE WITHIN THE FEMORAL ARTERY COMPLETELY NARROWING THE LUMEN. SURGICAL REMOVAL WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O