BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON

    MDR report key: 2100896 · Received May 13, 2011

    Report

    Report Number
    2100896
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 13, 2011
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 ENDOVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE DISTAL TIP OF THE MARATHON CATHETER WAS STUCK IN THE GLUE MASS AND RETAINED. PATIENT IS DOING WELL AND WAS DISCHARGED DAY AFTER PROCEDURE.NOTE: MD STATED THIS IS KNOWN TO HAPPEN WITH THIS PRODUCT AND FDA PROBABLY ALREADY AWARE. WE HAVE REPORTED ANYWAY HOWEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 ENDOVASCULAR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR