BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 2495652 · Received March 19, 2012

    Report

    Report Number
    2029214-2012-00155
    Event Type
    Injury
    Date Received
    March 19, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 22, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. TWO RUPTURES WERE FOUND AT APPROXIMATELY 11.3 CM AND 22CM FROM THE DISTAL TIP. THE CATHETER APPEARS TO HAVE RUPTURED DURING ONYX INJECTION 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 THAT AFTER ONYX EMBOLIZATION TREATMENT PROCEDURE, THE CATHETER WAS REMOVED FROM THE PATIENT AND FOUND RUPTURED AT 15-20CM FROM THE DISTAL TIP. NO PATIENT INJURY REPORTED. SAME EVENT AS MDR# 2029214-2012-00156.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 9532176

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability