BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLOW HPC 1.5F

    MDR report key: 1013317 · Received March 12, 2008

    Report

    Report Number
    2029214-2008-00037
    Event Type
    Injury
    Date Received
    March 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PREVIOUSLY TREATED FOR A BRAIN AVM AT ANOTHER HOSPITAL. AT THAT TIME, AN ULTRAFLOW CATHETER WAS USED TO DELIVER ONYX (EMBOLIC AGENT) AND BECAME ENTRAPPED IN THE BRAIN WHICH RESULTED IN A STROKE. SUBSEQUENTLY, THE CARE OF THE PATIENT HAS TRANSFERRED TO THIS HOSPITAL. THE DOCTOR EVALUATED AND OBSERVED ONE END OF THE CATHETER IN THE AORTA AND THE OTHER END ATTACHED IN THE AVM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC 1.5F FLOW DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5065

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability