BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 1940896 · Received December 23, 2010

    Report

    Report Number
    2029214-2010-00283
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 29, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION. (B)(4)

    Description of Event or Problem · 1

    TREATMENT OF A CEREBELLUM AVM WITH ONYX. IT WAS REPORTED AFTER THE AVM WAS EMBOLIZED WITH ONYX. IT WAS NOT POSSIBLE TO RETRACT THE CATHETER. THE CATHETER WAS REMOVED WITH FORCE AND CAUSED DISORDER IN THE RIGHT ABDUCENS NERVE AND LEFT AUDITORY NERVE. SAME EVENT AS MDR # 2029214-2010-00284.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5055 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention| S