BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON

    MDR report key: 7129318 · Received December 19, 2017

    Report

    Report Number
    2029214-2017-01365
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 21, 2017
    Report Date
    December 19, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MARATHON MICRO CATHETER WAS RETURNED FOR ANALYSIS AND DECONTAMINATED. THE TOTAL LENGTH OF THE MARATHON MICRO CATHETER WAS MEASURED AND THE USABLE LENGTH WAS FOUND TO BE WITHIN SPECIFICATIONS; HOWEVER, THE DISTAL FLOPPY SEGMENT WAS NOT. NO ISSUES WERE FOUND WITH THE MARATHON MICRO CATHETER HUB. NO BENDS OR KINKS WERE FOUND WITH THE MARATHON MICRO CATHETER BODY. THE SURFACE OF THE DISTAL FLOPPY SEGMENT OF THE MARATHON MICRO CATHETER WAS FOUND TO BE BUBBLED FOR THE LENGTH OF THE SEGMENT. THE ENTIRE SURFACE OF THE MARATHON MICRO CATHETER WAS EXAMINED UNDER MAGNIFICATION, NO PINHOLES OR RUPTURES WERE FOUND. HOWEVER, THE OUTER TUBING MATERIAL OF THE MARATHON MICRO CATHETER¿S DISTAL TIP WAS FOUND TO BE DAMAGED AND APPEARS TO BE TORN. WHAT APPEARS TO BE DRIED GLUE (NBCA) WAS FOUND ON THE OD OF THE MARATHON MICRO CATHETER DISTAL TIP. THE MARATHON MICRO CATHETER WAS PRESSURIZED WITH WATER AND FOUND NON-PATENT. NO OTHER ANOMALIES WERE OBSERVED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE PHYSICIAN WAS NOT ABLE TO SEE THE NBCA EMBOLIC COME OUT OF THE MIRCOCATHETER TIP AFTER INJECTION WAS STARTED. PRIOR TO THE EVENT, THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN NAVIGATED THE MICROCATHETER TO THE TARGET LESION AND THEN STARTED TO INJECT THE NBCA; HOWEVER, THE PHYSICIAN DID NOT SEE THE NBCA COME OUT OF THE CATHETER TIP. THE AMOUNT OF NBCA THAT WAS INJECTED WAS .028CC. FOR THIS REASON, THE MICROCATHETER WAS REMOVED FROM THE PATIENT AND CHECKED. NBCA WAS FOUND TO BE LEAKED ON A DRAPE AROUND THE SHEATH. A NEW MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF A BRAIN TUMOR. THE PATIENT ANATOMY WAS NOT REPORTED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910634 MARATHON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 105-5056 A449234

    Patients

    Seq Age Sex Outcome Treatment
    1