BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARATHON

    MDR report key: 4666141 · Received April 7, 2015

    Report

    Report Number
    2029214-2015-00346
    Event Type
    Death
    Date Received
    April 7, 2015
    Date of Event
    March 10, 2015
    Report Date
    March 10, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS CREATED TO CAPTURE THE EVENTS RELATED TO THE MARATHON CATHETER. THE MARATHON CATHETER WAS RETURNED FOR EVALUATION IN TWO SEGMENTS. ONYX WAS FOUND WITHIN THE CATHETER HUB AND WITHIN THE CATHETER LUMEN. THE PROXIMAL SEGMENT USEABLE LENGTH WAS MEASURED TO BE APPROXIMATELY 1.3CM. THE TUBING MATERIAL AT THE DISTAL END OF THE PROXIMAL SEGMENT AND AT THE PROXIMAL END OF THE DISTAL SEGMENT APPEARED TO HAVE A CLEAN SEPARATION. IT IS POSSIBLE THAT THE CATHETER MAY HAVE BEEN CUT (DISSECTED) INTO TWO SEGMENTS DURING REMOVAL OF THE CATHETER. THE PROXIMAL END OF THE DISTAL SEGMENT WAS ALSO FOUND TO BE DAMAGED. IT IS POSSIBLE THAT THIS DAMAGE MAY HAVE OCCURRED DURING RETRIEVAL OF THE CATHETER WITH A SNARE AS REPORTED IN THE COMPLAINT. THE DISTAL SEGMENTS USEABLE LENGTH WAS MEASURED TO BE APPROXIMATELY 162.9CM. THE COMBINED USEABLE LENGTHS WERE 164.2CM. THE DISTAL SEGMENT WAS FOUND TO BE KINKED AT APPROXIMATELY 23.0CM FROM THE DISTAL END. THE DISTAL FLOPPY SEGMENT WAS MEASURED TO BE APPROXIMATELY 21.4CM. THE TUBING MATERIAL OF THE DISTAL FLOPPY SEGMENT APPEARS TO HAVE BEEN STRETCHED WHICH IS POSSIBLY DUE TO THE REPORTED DIFFICULT REMOVAL OF THE CATHETER. IN ADDITION APPROXIMATELY 3.0CM OF THE CATHETER DISTAL SEGMENT AND MARKER BAND WERE FOUND TO BE MISSING. THE TUBING MATERIAL OF THE DISTAL END OF THE DISTAL SEGMENT WAS EXAMINED AND EXHIBITED JAGGED EDGES WITH EXPOSED ELLIPTICAL WIRES INDICATING THAT THE CATHETER BROKE AS IT WAS PULLED WITH FORCES EXCEEDING THE TENSILE STRENGTH OF THE TUBING MATERIAL. ALL CATHETERS ARE 100% INSPECTED FOR DAMAGE AND IRREGULARITIES DURING MANUFACTURE. NO OTHER ANOMALIES WERE OBSERVED. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN): DURING CEREBRAL ARTERIOVENOUS MALFORMATION / EMBOLIZATION, IT WAS REPORTED THE MARATHON MICROCATHETER COULD NOT BE REMOVED AFTER USING ONYX 18. FOR THAT REASON, THE PHYSICIAN USED SNARE 4MM TO RETRIEVE THE MICROCATHETER (INCLUDING THE DISTAL SEGMENT AND MARKER BAND). REMOVAL OF MICROCATHETER WAS SUCCESSFUL BUT HEMORRHAGE WAS OBSERVED FROM THE RIGHT VA. THE PHYSICIAN THEN PERFORMED OCCLUDING TREATMENT FOR THE VA PARENT VESSEL AND EMBOLIZED THE AREA WITH COILS. THE PHYSICIAN DETERMINED AND COMMENTED THE CAUSE OF DIFFICULTY IN THE CATHETER REMOVAL WAS DUE TO THE VESSEL TORTUOSITY AND REFLUX OF THE ONYX. THE VESSEL WAS TORTUOUS, MODERATE LEVEL, AND MODERATE SIZE IN DIAMETER. VASOSPASM WAS NOT OBSERVED. THE PHYSICIAN PAUSED DURING INJECTION BUT IT WAS LESS THAN 2 MINUTES. THE PAUSE TIME AFTER INJECTING ONYX WAS 2 MINUTES. THE FACILITY IS UNABLE TO VERIFY THE AMOUNT OF PRESSURE PLACED ON THE SYRINGE DURING THE ONYX INJECTION. THE INJECTION SPEED WAS SLOWER THAN USUAL. THE REFLUX SEEMED LESS THAN 1 CM UNDER IMAGING. THE DEAD SPACE OF THE DELIVERY CATHETER WAS FILLED WITH DMSO. MEDICAL INTERVENTION WAS REQUIRED. PROCEDURE EXTENDED OVER 30 MINUTES. THE PATIENT LAST KNOWN STATUS WAS BRAIN DEAD. THE PATIENT'S BASELINE STATUS WAS NOT PROVIDED. SAME EVENT AS MFR# 202914-2015-0351.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228458 MARATHON CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) 105-5056

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Death| R