BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID TRANSIT

    MDR report key: 216334 · Received March 26, 1999

    Report

    Report Number
    1058196-1999-00012
    Event Type
    Malfunction
    Date Received
    March 26, 1999
    Date of Event
    February 11, 1999
    Report Date
    March 26, 1999
    Manufacturer
    CORDIS ENDOVASCULAR SYSTEMS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING RE-EMBOLIZATION OF A GRANT ANEURYSM THE RAPID TRANSIT WAS PUSHED INTO THE ANEURYSM COIL MASS. APPROXIMATELY 10 GDC COILS WERE DELIVERED. WHEN THE RAPID TRANSIT WAS REMOVED, THE DISTAL MARKER BAND WAS UNWOVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID TRANSIT INFUSION MICROCATHETER DQO CORDIS ENDOVASCULAR SYSTEMS NA T1298003,T1198052,T0898068,

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other