BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON FLOW DIRECTED MICROC

    MDR report key: 2994268 · Received March 1, 2013

    Report

    Report Number
    MW5029230
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 5, 2013
    Report Date
    March 1, 2013
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MICROCATHETER FRAGMENT ENTRAPPED AFTER INJECTION OF ONYX LIQUID EMBOLIC AGENT. DECISION MADE TO LEAVE APPROXIMATELY 5 CM LONG FRAGMENT IN PATIENT AS IT WAS FELT TO POSE MINIMAL RISK TO PATIENT AND RISKS OF REMOVAL WERE FELT TO BE SIGNIFICANT. PATIENT WITH SYMPTOMATIC LEFT TRANSVERSE/SIGMOID A-V FISTULA. UNDERWENT ARTERIAL SUPPLY EMBOLIZATION ON (B)(6) 2013. CATHETER FRACTURED ON REMOVAL AND APPROXIMATE 5 CM FRAGMENT LEFT BEHIND IN PATIENT'S EXTERNAL CAROTID. FRAGMENT LEFT BEHIND AFTER DETERMINATION THAT RISKS RELATED TO REMOVAL EXCEED THE NEGLIGIBLE RISK OF LEAVING THE FRAGMENT BEHIND. PLAN TO RE-ANGIOGRAM THE PATIENT IN 6 MONTHS TO REASSESS. DATE OF USE: (B)(6) 2013. DIAGNOSIS: CEREBRAL ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89907 MARATHON FLOW DIRECTED MICROC FLOW DIRECTED MICROCATHETER KRA COVIDIEN 9637412

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR