BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER

    MDR report key: 478084 · Received August 15, 2003

    Report

    Report Number
    2029214-2003-00030
    Event Type
    Injury
    Date Received
    August 15, 2003
    Date of Event
    July 9, 2003
    Report Date
    July 16, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT OF A BRAIN AVM, AS THE CATHETER WAS BEING NAVIGATED INTO THE DISTAL VASCULATURE, THE PATIENT EXPERIENCED A SAH. NO CLINICAL SEQUELAE.

    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 921274J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention