BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 1760403 · Received July 8, 2010

    Report

    Report Number
    2029214-2010-00138
    Event Type
    Injury
    Date Received
    July 8, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 10, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROX 7.2 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. RESULTS: CATHETER RUPTURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ONYX INJECTION, THE CATHETER BURST AND ONYX WAS OBSERVED LEAKING AT THE PROXIMAL PART OF THE CATHETER. NO PT INJURY REPORTED. SAME EVENT AS MDR # 20209214-2010-00139.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5055 8387144

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability