BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON MICROCATHETER

    MDR report key: 4233597 · Received November 6, 2014

    Report

    Report Number
    2029214-2014-00637
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR EVALUATION AND THE DISTAL MARKER BAND WAS FOUND TO BE CRUSHED. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM (ARTERIOVENOUS MALFORMATION). ON (B)(6) 2014, THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE DISTAL MARKER BAND OF THE MARATHON AND GUIDEWIRE WERE NOT ALIGNED AS IT WAS ADVANCED THROUGH A CURVE IN THE BLOOD VESSEL. THE PHYSICIAN DECIDED TO REMOVE THE MARATHON AND GUIDEWIRE AS A WHOLE AND DISCOVERED THAT THE TIP OF THE MARATHON WAS BROKEN. THE CATHETER TIP WAS ALSO REMOVED FROM THE PATIENT. ANOTHER MARATHON WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THE PATIENT WAS DISCHARGED NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715341 MARATHON MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) 105-5055 9839217

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR