BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 2010338 · Received March 8, 2011

    Report

    Report Number
    2029214-2011-00045
    Event Type
    Injury
    Date Received
    March 8, 2011
    Report Date
    February 9, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 6.9 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. (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

    TREATMENT OF AN AVM. IT WAS REPORTED THAT THE PATIENT'S AVM WAS TREATED WITH ONYX AND THE CATHETER WAS LEFT INSIDE THE PATIENT DUE TO ENTRAPMENT. THREE YEARS AFTER THE TREATMENT, THE PATIENT CAME BACK AND REPORT THE CATHETER HAS INDUCED PATIENT INJURY DUE TO THE CATHETER WAS LEFT INSIDE THE ARTERY (LEG THROMBOPHLEBITIS AND NECROSIS AT THE LEVEL OF THE HEEL). THE CATHETER WAS REMOVED VIA SURGERY AND THE PATIENT HAS RECOVERED. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT. SAME EVENT AS MDR# 2029214-2011-00046.

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. IT WAS REPORTED THAT THE PATIENT'S AVM WAS TREATED WITH ONYX AND THE CATHETER WAS LEFT INSIDE THE PATIENT DUE TO ENTRAPMENT. THREE YEARS AFTER THE TREATMENT, THE PATIENT CAME BACK AND REPORT THE CATHETER HAS INDUCED PATIENT INJURY DUE TO THE CATHETER WAS LEFT INSIDE THE ARTERY (LEG THROMBOPHLEBITIS AND NECROSIS AT THE LEVEL OF THE HEEL). THE CATHETER WAS REMOVED VIA SURGERY AND THE PATIENT HAS RECOVERED. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT. SAME EVENT AS MDR# 2029214-2011-00046.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 3424407

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention