BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLOW HPC 1.5F

    MDR report key: 1040023 · Received May 7, 2008

    Report

    Report Number
    2029214-2008-00090
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 15, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. DURING ONYX INJECTION, IT WAS REPORTED THE CATHETER LEAKED AND ONYX WAS SEEN EXITING PROXIMAL TO THE TIP. AS A RESULT, THE PHYSICIAN CLOSED THE VERTEBRAL ARTERY WITH EMBOLIC COILS. THE PT HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC 1.5F FLOW DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5066 4749315

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability