BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 1556458 · Received December 8, 2009

    Report

    Report Number
    2029214-2009-00324
    Event Type
    Injury
    Date Received
    December 8, 2009
    Date of Event
    July 22, 2009
    Report Date
    September 2, 2009
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION. MODEL# AND LOT # OF THE ONYX USED: MODEL# 105-7100-060, LOT# 7279662 (QTY 3EA), 7471460 (QTY: 2EA). DOM 03/2009, 06/2009. EXPIRATION DATE 12/2011, 04/2011.

    Description of Event or Problem · 1

    TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED THE PHYSICIAN EMBOLIZED 5 FEEDERS OF THE AVM USING 4 MARATHON CATHETERS AND INJECTED APPROXIMATELY 3.85ML OF ONYX. ONE OF THE CATHETERS WAS EXPERIENCED DIFFICULTY DURING REMOVAL AND THE PATIENT SHOWED SAH. NO COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5055 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention