BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLOW HPC 1.5F MICRO CATHETER

    MDR report key: 614510 · Received June 17, 2005

    Report

    Report Number
    2029214-2005-00039
    Event Type
    Death
    Date Received
    June 17, 2005
    Date of Event
    May 2, 2005
    Report Date
    June 17, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CATHETER BROKE IN THE LATERAL PART WHICH ALLOWED THE EMBOLIC ONYX OVERFLOWED THROUGH THE PT CIRCULATION. THE PHYSICIAN TRIED TO OPEN THE OBSTRUCTED ARTERY WITH HYPERGLIDE BALLOON. THE PT HAD A MEDIA CEREBRAL ARTERY ISCHEMIA EVOLVING TO A SERIOUS NEUROLOGICAL DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC 1.5F MICRO CATHETER FLOW-DIRECTED MICRO CATHETER KRA MICRO THERAPEUTICS, INC. 105-5065 631795

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Death