BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 2417798 · Received January 17, 2012

    Report

    Report Number
    2029214-2012-00027
    Event Type
    Injury
    Date Received
    January 17, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 5.6 CM FROM THE DISTAL TIP. THE APPEARANCE OF THE CATHETER IS CONSISTENT WITH A RUPTURE CAUSED BY OVER-PRESSURIZATION AS A RESULT OF AN UNDETECTED KINK OR OTHER OBSTRUCTION WITHIN THE CATHETER. CATHETER RUPTURE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. IT WAS REPORTED THAT THE CATHETER RUPTURED DURING ONYX INJECTION. CONSEQUENTLY, ONYX WAS OBSERVED IN AN UNINTENDED ARTERY. NO COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT. SAME EVENT AS MDR# 2029214-2012-00028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 9486105

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability