BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 2426784 · Received January 24, 2012

    Report

    Report Number
    2029214-2012-00038
    Event Type
    Injury
    Date Received
    January 24, 2012
    Date of Event
    December 29, 2011
    Report Date
    January 5, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 24.3 CM FROM THE DISTAL TIP. THE CATHETER APPEARS TO HAVE RUPTURED DUE TO OVER-PRESSURIZATION AS A RESULT OF AN OCCLUSION (I.E. SOLIDIFIED ONYX / KINK) WITHIN THE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER RUPTURED DURING ONYX INJECTION. NO PATIENT INJURY REPORTED. SAME EVENT AS MDR# 2029214-2012-00039.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 9504865

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability