BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 627197 · Received August 15, 2005

    Report

    Report Number
    2029214-2005-00058
    Event Type
    Malfunction
    Date Received
    August 15, 2005
    Date of Event
    July 13, 2005
    Report Date
    August 15, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MARATHON CATHETER WAS USED IN A SPINAL AVM PROCEDURE, THE CATHETER WAS PLACED THROUGH A SFR ENVOY WITH SYNCHRO 10 GUIDEWIRE. PROCEEDED TO INJECT CONTRAST MEDIUM ONLY AND THEM DID NOT PROCEED WITH THE CASE. WHEN CATHETER WAS REMOVED FROM THE PATIENT, IT WAS FOUND TO HAVE A CLEAN FRACTURE ABOUT 75CM FROM THE DISTAL TIP. NO PATIENT INJURY REPORTED.

    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 1073375

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other