BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 2462422 · Received February 21, 2012

    Report

    Report Number
    2029214-2012-00073
    Event Type
    Injury
    Date Received
    February 21, 2012
    Date of Event
    November 7, 2011
    Report Date
    January 25, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. IT WAS REPORTED DURING THE SEVENTH AVM EMBOLIZATION TREATMENT WITH ONYX VIA MARATHON CATHETER, AFTER INJECTED 0.7ML OF ONYX, CONTRAST MEDIA WAS OBSERVED LEAKS OUT OF THE VESSEL WHEN TAKEN IMAGES BY DIGITAL SUBTRACTION ANGIOGRAPHY. THE PHYSICIAN COMMENTED THAT THE CATHETER AND GUIDEWIRE MANIPULATION WAS THE CAUSE OF THE EVENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention