BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON

    MDR report key: 4690436 · Received April 14, 2015

    Report

    Report Number
    2029214-2015-00366
    Event Type
    Injury
    Date Received
    April 14, 2015
    Date of Event
    March 11, 2015
    Report Date
    March 16, 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

    ONE CATHETER WAS RETURNED FOR EVALUATION. ONYX WAS FOUND WITHIN THE CATHETER HUB. THE USEABLE LENGTH OF THE CATHETER WAS MEASURED AND FOUND WITHIN SPECIFICATION. THE CATHETER WAS FOUND TO BE RUPTURED AT APPROXIMATELY 146.7CM FROM THE CATHETER HUB. THE CATHETER APPEARED TO HAVE RUPTURED DUE TO OVER-PRESSURIZATION AS A RESULT OF AN OCCLUSION (I.E. SOLIDIFIED ONYX / KINK) WITHIN THE CATHETER, RESULTING IN PRESSURES EXCEEDING THE LIMITS OF THE CATHETER. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGE AND IRREGULARITIES DURING MANUFACTURE. IN ADDITION, THE LOT HISTORY RECORDS OF THE REPORTED LOT NUMBERS HAVE BEEN REVIEWED AND NO QUALITY ISSUES WERE NOTED. UPDATED SUSPECT MEDICAL DEVICE - LOT NUMBER: 9920977, DATE OF MANUFACTURE 06/02/2014, EXPIRATION DATE: 05/14/2017. ADDITIONAL LOT NUMBER PROVIDED: A026778, DATE OF MANUFACTURE: 12/05/2014, EXPIRATION DATE: 11/25/2017. REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS CREATED TO CAPTURE THE MARATHON CATHETER RELATED TO THIS EVENT. RESULTS OF THE INVESTIGATION IS PENDING, A SUPPLEMENTAL WILL BE SUBMITTED UPON COMPLETION. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING REPORT WAS RECEIVED MY MEDTRONIC (COVIDIEN): DURING A PROCEDURE, THE PHYSICIAN APPROACHED THE TARGET LESION WITH THE MARATHON MICROCATHETER, AND IMPLANTED A COIL IN ORDER TO REDUCE THE FLOW, THEN STARTED INJECTING ONYX 18. HOWEVER, THE PHYSICIAN FELT SLIGHT RESISTANCE. FOR THAT REASON, HE USED ANOTHER ONYX, BUT STILL FELT RESISTANCE. THE PHYSICIAN STOPPED INJECTING ONYX, AND TRIED TO TAKE CONTRAST IMAGE AND FOUND THE MARATHON MICROCATHETER BURSTED AND ONYX WAS LEAKING AT THE INTERNAL CAROTID ARTERY (IC) NEAR THE OSTIAL PART OF GUIDING CATHETER. THE PHYSICIAN TRIED TO RETRIEVE THE ONYX BUT ONLY HALF OF IT WAS RETRIEVED, AND THE REST WAS LEFT AT THE OSTIAL PART OF THE EXTERNAL CAROTID ARTERY. SINCE THE EXTERNAL CAROTID HAD FLOW AND COLLATERAL CIRCULATION FROM THE IC WAS OBSERVED, THE PHYSICIAN WAS CONCERNED ABOUT THE REMAINED ONYX MIGRATING TO THE INTERNAL CAROTID ARTERY (IC) PERIPHERAL CAUSED BY ADDITIONAL TREATMENT, AND DECIDED TO FOLLOW CLOSELY WITHOUT FURTHER TREATMENT. FOR ARTERIOVENOUS MALFORMATION TREATMENT (AVM), THE PHYSICIAN USED ANOTHER MARATHON CATHETER AND N-BUTYL CYANOACRYLATE (NBCA) TO CONTINUE. THE SECOND MARATHON MICROCATHETER WAS DELIVERED FROM ANOTHER ROUTE TO INJECT NBCA. THE VESSEL WAS NOT TORTUOUS BUT SMALL IN DIAMETER THE PHYSICIAN CONSIDERED THE CAUSE OF THE MARATHON MICROCATHETER BURST WAS DEPOSITION OF ONYX INSIDE THE CATHETER. HE ALSO THOUGHT OF THE POSSIBILITY OF FEWER SALINE BEING USED DURING PREPARATION, AND OR THE CATHETER LUMEN BEING DAMAGED DURING IMPLANT OF ED COIL. THE ONYX LEFT INSIDE THE PATIENT WAS EVENTUALLY RETRIEVED BY SUCTIONING FROM THE GUIDING CATHETER USING SOLITAIRE FR 6-30. PER PHYSICIAN, IT COULD NOT BE IDENTIFIED WHICH LOT NUMBER OF MARATHON MICROCATHETER WAS THE FIRST ONE OR THE SECOND ONE USED DURING THE PROCEDURE. INFORMATION RECEIVED FROM THE SAME REPORT AS MDR# 2029214-2015-00367.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247831 MARATHON CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) 105-5056 9920977

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other| R