BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON

    MDR report key: 7132027 · Received December 19, 2017

    Report

    Report Number
    2029214-2017-01368
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    October 24, 2017
    Report Date
    February 1, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MARATHON MICRO CATHETER WAS RETURNED FOR ANALYSIS AND WAS DECONTAMINATED. THE USABLE LENGTH OF THE MARATHON MICRO CATHETER WAS MEASURED AND NOT FOUND WITHIN SPECIFICATIONS. APPROXIMATELY 25.0 CM OF THE MICRO CATHETER DISTAL FLOPPY SEGMENT WAS FOUND TO BE MISSING. THE MISSING SEGMENT WAS REPORTED TO HAVE REMAINED WITHIN THE PATIENT. THE TUBING MATERIAL AT THE DISTAL BROKEN END EXHIBITED JAGGED EDGES, NECKING, AND STRETCHING. NO DAMAGES OR ISSUES WERE FOUND WITH THE MARATHON MICRO CATHETER HUB. INSPECTION OF THE REMAINDER OF THE MARATHON, APART FROM THE OBSERVED SEPARATION, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. NO OTHER ANOMALIES WERE OBSERVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. ONCE THE DEVICE HAS BEEN RETURNED, AN ANALYSIS WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE DEVICE ANALYSIS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT DURING A BRAIN TUMOR EMBOLIZATION PROCEDURE, THE MICROCATHETER TIP BROKE AND SEPARATED DURING THE DELIVERY. THE SEPARATED PIECE WAS LEFT IN THE MIDDLE MENINGEAL ARTERY (MMA). THE USER STATED THAT THE SEPARATED MICROCATHETER PIECE WOULD NOT AFFECT THE PATIENT, THEREFORE, THE PIECE WAS LEFT IN THE MMA. NEW DEVICES WERE SELECTED, AND THE PROCEDURE WAS COMPLETED. THE PROCEDURE WAS EXTENDED FOR OVER 30 MINUTES. THE PATIENT WAS ASYMPTOMATIC POST INTERVENTION. THE CATHETER WILL BE RETURNED FOR ANALYSIS WITHOUT THE BROKEN PIECE AS IT REMAINS THE PATIENT. REGARDING THE PATIENT ANATOMY, NO INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910203 MARATHON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 105-5056 A434102

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Disability