BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 1881371 · Received October 7, 2010

    Report

    Report Number
    2029214-2010-00216
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 9, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. THE CATHETER WAS FOUND RUPTURED AT 9.9 CM FROM THE DISTAL TIP. THE CATHETER APPEARS TO HAVE RUPTURED DURING ONYX DELIVERY DUE TO OVER-PRESSURIZATION AS A RESULT OF AN OCCLUSION WITHIN THE CATHETER. CATHETER RUPTURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ONYX INJECTION, ONYX WAS NOTED LEAKING PROXIMALLY FROM THE DISTAL TIP OF THE CATHETER. SAME EVENT AS MDR # 2029214-2010-00217.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5055 8337463

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK