BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER

    MDR report key: 487295 · Received October 1, 2003

    Report

    Report Number
    2029214-2003-00037
    Event Type
    Death
    Date Received
    October 1, 2003
    Date of Event
    September 1, 2003
    Report Date
    September 1, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS TO EMBOLIZE FORU PEDICLES OF A BRAIN FISTULA. ON THE THIRD PEDICLE TREATED, AND WHILE INJECTING NBCA EMBOLIC GLUE, THE PHYSICIAN OBSERVED THAT IT WAS TAKING LONGER THAN EXPECTED FOR THE GLUE TO EXIT THE CATHETER TIP. VIA ANGIOGRAPHY, IT WAS DETERMINED THAT THERE WAS AN UNANTICIPATED ICA OCCLUSION WITH THE NBCA GLUE. THE PATIENT HAD A STROKE. ANGIOGRAPHY INJECTIONS PRIOR TO THE GLUE INJECTION WERE UNEVENTFUL. DUE TO THE TORTUOUS ANATOMY, A GUIDEWIRE HAD TO BE USED FOR ACCESS TO EACH PEDICLE. A GUIDE CATHETER COULD NOT BE USED DUE TO THE ANATOMY OF THE PATIENT.

    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 79751

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R 3. MTI X-PEDION .010" GUIDEWIRE.| 1. TRUFIL N-BCA EMBOLIC GLUE,| 2. MTI MIRAGE .008" GUIDEWIRE,