BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 2230742 · Received September 1, 2011

    Report

    Report Number
    2029214-2011-00230
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 7 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

    TREATMENT OF AN AVM. IT WAS REPORTED THE CATHETER RUPTURED AT 3CM FROM THE DISTAL TIP AFTER APPROXIMATELY 20 MINUTES OF ONYX INJECTION.NO PATIENT INJURY REPORTED.SAME EVENT AS MDR# 2029214-2011-00231

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 8013486

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability