BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICROCATHETER

    MDR report key: 4112815 · Received September 17, 2014

    Report

    Report Number
    2029214-2014-00530
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    August 19, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR EVALUATION AND IT WAS FOUND TO BE RUPTURED AT APPROXIMATELY 6CM FROM THE DISTAL TIP OF THE CATHETER. THE CATHETER APPEARED TO HAVE BEEN RUPTURED DURING THE ONYX DELIVERY DUE TO OVER-PRESSURIZATION AS A RESULT OF AN UNDETECTED KINK OR OTHER OBSTRUCTION OF THE CATHETER, RESULTING IN PRESSURES EXCEEDING THE LIMITS OF THE CATHETER. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGE AND IRREGULARITIES DURING MANUFACTURE. PER THE ONYX INSTRUCTION FOR USE: STOP INJECTION IF INCREASED RESISTANCE TO ONYX LES INJECTION IS OBSERVED. IF INCREASED RESISTANCE OCCURS, DETERMINE THE CAUSE (E.G., ONYX LES OCCLUSION IN CATHETER LUMEN) AND REPLACE THE CATHETER. DO NOT ATTEMPT TO CLEAR OR OVERCOME RESISTANCE BY APPLYING INCREASED INJECTION PRESSURE, AS USE OF EXCESSIVE PRESSURE MAY RESULT IN CATHETER RUPTURE AND EMBOLIZATION OF UNINTENDED AREAS. DO NOT INTERRUPT ONYX LES INJECTION FOR LONGER THAN TWO MINUTES PRIOR TO RE-INJECTION. SOLIDIFICATION OF ONYX LES MAY OCCUR AT THE CATHETER TIP RESULTING IN CATHETER OCCLUSION, AND USE OF EXCESSIVE PRESSURE TO CLEAR THE CATHETER MAY RESULT IN CATHETER RUPTURE. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT ON AN UNSPECIFIED DATE. DURING THE ONYX INJECTION, IT WAS REPORTED THE ONYX WAS LEAKING DUE TO A BREAK IN THE MICROCATHETER. NO FURTHER INFORMATION WAS AVAILABLE. SAME EVENT AS MDR# 2029214-2014-00543.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576100 MARATHON MICROCATHETER FLOW-DIRECTED MICROCATHETER DYG EV3 NEUROVASCULAR 105-5055 9595427

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability