BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 3950473 · Received July 22, 2014

    Report

    Report Number
    2029214-2014-00428
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    June 24, 2014
    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 WAS RETURNED FOR EVALUATION AND IT WAS FOUND TO BE RUPTURED AT APPROXIMATELY 6.5CM FROM THE DISTAL TIP OF THE CATHETER AND DAMAGED AT APPROXIMATELY 1.5CM FROM THE DISTAL TIP. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    REFERENCE (B)(4) FOLLOW-UP 2.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TREATMENT OF AN AVM (ARTERIOVENOUS MALFORMATION). ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT. DURING THE ONYX INJECTION, IT WAS REPORTED THE MARATHON CATHETER RUPTURED. A TOTAL OF SEVEN VIALS OF ONYX WERE USED. NO FURTHER INFORMATION WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2014-00429.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428289 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 9864616

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability