BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON MICROCATHETER

    MDR report key: 6952612 · Received October 16, 2017

    Report

    Report Number
    2029214-2017-01148
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    September 21, 2017
    Report Date
    December 4, 2017
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROCATHETER WAS RETURNED FOR ANALYSIS. THE GUIDEWIRE WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE SITE. THE MICROCATHETER WAS DECONTAMINATED AND THE TOTAL LENGTH OF THE MICROCATHETER WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. NO ISSUES WERE FOUND WITH THE MICROCATHETER HUB. THE MICROCATHETER BODY WAS FOUND TO BE PUNCTURED AT NEAR THE DISTAL TIP. INSPECTION OF THE REMAINDER OF THE MICROCATHETER BODY, APART FROM THE OBSERVED PUNCTURE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. NO ISSUES WERE FOUND WITH THE MICROCATHETER DISTAL TIP. AN UNSUCCESSFUL ATTEMPT WAS MADE TO FLUSH THE MICROCATHETER WITH WATER AS IT WAS FOUND TO BE OCCLUDED WITH WHAT IS LIKELY TO BE DRIED CONTRAST. THE MICROCATHETER COULD NOT BE USED FOR TESTING WITH AN IN-HOUSE GUIDEWIRE AS IT WAS FOUND TO BE OCCLUDED. NO OTHER ANOMALIES WERE OBSERVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MARATHON MICROCATHETER HAS BEEN RETURNED FOR EVALUATION. ONCE COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS FROM THIS EVENT: 2029214-2017-01149. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT WHEN ADVANCING THE SILVERSPEED GUIDEWIRE THROUGH THE MARATHON MICROCATHETER, IT DID NOT FOLLOW THE SAME TRAJECTORY AS THE CATHETER WHILE IN THE PATIENT. THE MICROCATHETER WAS PUNCTURED BY THE GUIDEWIRE. IT WAS REPORTED THAT AFTER THE MICROCATHETER AND GUIDEWIRE WERE REMOVED, DAMAGE WAS OBSERVED AT THE DISTAL END OF THE MICROCATHETER. THE MICROCATHETER WAS REPLACED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS RECEIVING EMBOLIZATION TREATMENT. VESSEL TORTUOSITY WAS MINIMAL AND ACCESS VESSEL WAS THE MIDDLE MENINGEAL OFF THE EXTERNAL CAROTID ARTERY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED AS DIRECTED. THE TIP OF THE WIRE WAS SHAPED, BUT TIP OF THE CATHETER WAS NOT. THERE WAS NO FRICTION OR DIFFICULTY DURING INSERTION OF THE GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732544 MARATHON MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 105-5056 A429944

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR