BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLOW HPC FLOR-DIRECTED MICRO CATHETER

    MDR report key: 472095 · Received July 17, 2003

    Report

    Report Number
    2029214-2003-00024
    Event Type
    Death
    Date Received
    July 17, 2003
    Date of Event
    June 4, 2003
    Report Date
    June 20, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN AVM EMBOLIZATION PROCEDURE, THE CATHETER RUPTURED WHEN CONTRAST MEDIA WAS INJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC FLOR-DIRECTED MICRO CATHETER NEURO MICRO CATHETER KRA MICRO THERAPEUTICS, INC. 105-5065 920794J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN