BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER

    MDR report key: 464558 · Received June 5, 2003

    Report

    Report Number
    2029214-2003-00016
    Event Type
    Malfunction
    Date Received
    June 5, 2003
    Date of Event
    May 2, 2003
    Report Date
    May 2, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS FOR TREATMENT OF A DURAL AV FISTULA. AFTER INJECTING 150-250 MICRON PVA PARTICLES, AND UPON CATHETER WITHDRAWAL, THE CATHETER SEPARATED APPROXIMATELY 8CM FROM THE DISTAL TIP. THE REMAINING DISTAL SEGMENT WAS RETRIEVED USING A SNARE.

    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 890894J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN