BEUDAMED
    FDA Adverse Event Summary report: N

    MARATHON FLOW DIRECTED MICRO CATHETER

    MDR report key: 1003932 · Received January 31, 2008

    Report

    Report Number
    1003932
    Date Received
    January 31, 2008
    Date of Event
    December 14, 2007
    Report Date
    December 17, 2007
    Manufacturer
    MICRO THERAPEUTICS,INC.
    Product Code
    KRA
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING EMBOLIZATION OF AN ARTERIAL/VENOUS DEFECT IN THE BRAIN. SUBSTANCE WAS INJECTED TO CREATE THE EMBOLUS. THE MICRO CATHETER IS DESIGNED NOT TO "STICK" TO THE SUBSTANCE FOLLOWING INJECTION. IT APPARENTLY DID STICK AND THEN BROKE OFF LEAVING A PIECE OF THE MICRO CATHETER IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON FLOW DIRECTED MICRO CATHETER CATHETER, NEUROVASCULAR KRA MICRO THERAPEUTICS,INC. * 1315653

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR