BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 1972782 · Received January 28, 2011

    Report

    Report Number
    2029214-2011-00019
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 18 CM FROM THE DISTAL TIP. THE APPEARANCE OF THE CATHETER IS CONSISTENT WITH A RUPTURE CAUSED BY OVER-PRESSURIZATION AS A RESULT OF AN UNDETECTED KINK OR OTHER OBSTRUCTION WITHIN THE CATHETER.CATHETER RUPTURE.(B)(4)

    Description of Event or Problem · 1

    EMBOLIZATION TREATMENT OF A DURAL FISTULA WITH ONYX. DURING ONYX INJECTION, IT WAS REPORTED THE CATHETER RUPTURED AT APPROXIMATELY 6CM FROM THE DISTAL TIP.NO PATIENT INJURY REPORTED.SAME EVENT AS MDR# 2029214-2011-00020

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5055 9309022

    Patients

    Seq Age Sex Outcome Treatment
    1