BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EV3 NEUROVASCULAR

    MDR report key: 2100935 · Received May 18, 2011

    Report

    Report Number
    MW5020675
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 18, 2011
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ULTRAFLOW HPC FLOW CATHETER BEING USED FOR ENDOVASCULAR AVM EMBOLIZATION. NEAR TERMINATION OF THE PROCEDURE NON-TARGET EMBOLIZATION WAS NOTED AS SCATTERED THROUGH THE MIDDLE CEREBRAL ARTERY BRANCHES. PROCEDURE TERMINATED, MICROCATHETER WITHDRAWN. CATHETER HAD FRACTURE 6 CM PROXIMAL TO MICROCATHETER TERMINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EV3 NEUROVASCULAR ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER KRA 7633843

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization