BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 1983889 · Received February 10, 2011

    Report

    Report Number
    2029214-2011-00029
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    December 18, 2010
    Report Date
    January 11, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURED WAS FOUND AT APPROXIMATELY 6.9CM FROM THE DISTAL TIP. THE APPEARANCE OF THE CATHETER IS CONSISTENCE WITH A RUPTURE CAUSED BY OVER-PRESSURIZATION AS A RESULT OF AN UNDETECTED KINK OR OTHER OBSTRUCTION WITHIN THE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    EMBOLIZATION TREATMENT OF A DAVF. IT WAS REPORTED THE CATHETER RUPTURED DURING ONYX INJECTION.NO PATIENT INJURY REPORTED.SAME EVENT AS MDR# 2029214-2011-00030.

    Description of Event or Problem · 1

    EMBOLIZATION TREATMENT OF A DAVF. IT WAS REPORTED THE CATHETER RUPTURED DURING ONYX INJECTION. NO PATIENT INJURY REPORTED. SAME EVENT AS MDR# 2029214-2011-00030

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 9180372

    Patients

    Seq Age Sex Outcome Treatment
    1