BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 673760 · Received February 10, 2006

    Report

    Report Number
    2029214-2006-00021
    Event Type
    Death
    Date Received
    February 10, 2006
    Date of Event
    January 10, 2006
    Report Date
    February 2, 2006
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A MARATHON WAS USED IN A TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED THE CATHETER BECAME ENTRAPPED, DURING PROCEDURE. WHILE CATHETER RETRIEVEAL WAS DIFFICULT, THERE WAS NO SIGN OF THE PT BLEEDING. HOWEVER, ONE HOUR LATER, THE PT BLED. PHYSICIAN WAS NOT SURE IF BLEEDING WAS DUE TO DIFFICULT CATHETER RETRIEVAL OR JUST HEMODYNAMICS CHANGE WITHIN THE AVM. THE PT CONDITION WAS NOT REPORTED, ON FOLLOW-UP, IT WAS REPORTED THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW DIRECTED MICRO CATHETER KRA MICRO THERAPEUTICS, INC. 105-5055 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death