BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSEAL VASCULAR CLOSURE DEVICE

    MDR report key: 1881657 · Received September 27, 2010

    Report

    Report Number
    1881657
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US

    Narratives

    Description of Event or Problem · 1

    AFTER LEFT HEART CATHETERIZATION, ANGIOSEAL WAS SUCCESSFULLY DEPLOYED. PATIENT LATER DEVELOPED A PSEUDOANEURYSM OF THE RIGHT COMMON FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL * 3128823

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR