BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 2464747 · Received February 22, 2012

    Report

    Report Number
    2029214-2012-00078
    Event Type
    Injury
    Date Received
    February 22, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 10, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 148CM OF THE BROKEN PROXIMAL PORTION OF THE CATHETER WAS RETURNED FOR EVALUATION WITH 22 CM OF THE DISTAL TIP MISSING, WHICH WAS REPORTED REMAINING IN THE PATIENT. EXAMINATION OF THE BROKEN END SHOWED THE CATHETER WAS PULLED BEYOND ITS MATERIAL STRENGTH AND SEPARATED. CATHETER SEPARATED. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. IT WAS REPORTED AFTER 20 MINUTES OF ONYX INJECTION WITH ONYX REFLUX, THE CATHETER FRACTURED APPROXIMATELY 24CM FROM THE DISTAL TIP DURING REMOVAL AND THE BROKEN SEGMENT REMAINED IN THE PATIENT. SAME EVENT AS MDR# 2029214-2012-00079.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 9417340

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability