BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER, EXTENDED LENGTH

    MDR report key: 481528 · Received August 29, 2003

    Report

    Report Number
    2029214-2003-00034
    Event Type
    Other
    Date Received
    August 29, 2003
    Date of Event
    July 23, 2003
    Report Date
    August 26, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUCCESSFUL EMBOLIZATION OF A PARIETAL BRAIN AVM VIA THE ACA. AFTER WITHDRAWAL OF THE CATHETER, THE PHYSICIAN NOTICED A STRING OF ONYX AT THE ICA BIFURCATION. WHILE INJECTING ONXY, NO RESISTANCE WAS FELT, AN ONYX EXITED THE DISTAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER, EXTENDED LENGTH NEURO MICRO CATHETER KRA MICRO THERAPEUTICS, INC 105-5066 931484J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other