BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 3002627 · Received March 13, 2013

    Report

    Report Number
    2029214-2013-00228
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 6.1CM 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 OR AN UNDETECTED KINK, RESULTING IN PRESSURES EXCEEDING THE LIMITS OF THE CATHETER. RESULTS: CATHETER RUPTURE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM (ARTERIOVENOUS MALFORMATION). DURING ONYX INJECTION, IT WAS REPORTED THAT THE MARATHON CATHETER RUPTURED AND SEPARATED AT APPROXIMATELY 5CM FROM THE DISTAL TIP. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2013-00229

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104637 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 9682602

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability