BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER

    MDR report key: 431482 · Received December 4, 2002

    Report

    Report Number
    2029214-2002-00016
    Event Type
    Other
    Date Received
    December 4, 2002
    Date of Event
    October 10, 2002
    Report Date
    November 26, 2002
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING CONTRAST MEDIA INJECTION, THE CATHETER RUPTURED BETWEEN THE VERY FLEXIBLE AND LESS FLEXIBLE PART OF THE ULTRAFLOW. APPROXIMATELY 15 CM OF THE ULTRAFLOW REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER PERCUTANEOUS INTRAVASCULAR CATHETER KRA MICRO THERAPEUTICS, INC. 105-5065 892704J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN