BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 1081459 · Received July 25, 2008

    Report

    Report Number
    2029214-2008-00127
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 24.2 CM 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. CATHETER RUPTURE.

    Description of Event or Problem · 1

    TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED DURING ONYX INJECTION, THE PHYSICIAN NOTICED ONYX WAS NOT ARRIVING AT THE SITE AND AS THE CATHETER HAD RUPTURED. UNDER X-RAY, THE PHYSICIAN WIDENED THE VIEW AND NOTED ONYX HAD EMBOLIZED THE GASTRODUODENAL ARTERY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5055 3856456

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability