BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER

    MDR report key: 499768 · Received November 25, 2003

    Report

    Report Number
    2029214-2003-00042
    Event Type
    Malfunction
    Date Received
    November 25, 2003
    Date of Event
    October 17, 2003
    Report Date
    October 23, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN EMBOLIC AGENT WAS BEING DELIVERED THROUGH THE ULTRAFLOW CATHETER. THE PHYSICIAN INITIALLY HAD DIFFICULTY WITH VISUALIZATION OF THE EMBOLIC MATERIAL, AND THE REFLUX WAS NOT CONTROLLED PER THE INSTRUCTION FOR USE. THE CATHETER COULD NOT BE WITHDRAWN AND WAS CUT AND LEFT IN PLACE. TOWARD THE END OF THE PROCEDURE, THE CATHETER RELEASED FROM THE EMBOLIC MATERIAL AND WAS THEN RETRIEVED VIA A CONTRALATERAL ACCESS SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER NEURO MICRO CATHETER KRA MICRO THERAPEUTICS, INC. 105-5065 79343

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ONYX LIQUID EMBOLIC AGENT.