BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLOW

    MDR report key: 510293 · Received February 5, 2004

    Report

    Report Number
    MW4003650
    Event Type
    Injury
    Date Received
    February 5, 2004
    Date of Event
    November 21, 2002
    Manufacturer
    MICRO THERAPEUTICS INC
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD A FAILED SUPER SELECTIVE EMBOLIZATION IN ANOTHER COUNTRY. APPARENTLY THE CATHETER WALL RUPTURED DURING THE PROCEDURE. MFR HAS ADVISED THAT NOTHING IS WRONG WITH THEIR PRODUCT. GLUE LEAKED OUT AND FILLED RHS VERTEBRAL ARTERY AND PT HAD A NEAR FATAL BRAIN STEM STROKE FROM THE GLUE SOME 48 HOURS LATER. IT HAS SINCE TRANSPIRED THAT THE FDA AND THE MFR WERE ADVISED OF THIS ADVERSE INCIDENT. SOME 9 MONTHS LATER THE MINUTES OF A MEDICAL DEVICES ADVISORY COMMITTEE, NEUROLOGICAL DEVICES PANEL PT SEEM TO CONTRADICT THIS. AS MFR'S PREVIOUS MODELS OF CATHETER (FLOW RIDER AND FLOW RIDER PLUS) WERE RECALLED AND CHANGES MADE DUE TO SEVERE RUPTURES, PT ASKS IF THERE IS SOMETHING FISHY GOING ON HERE. PT FEELS PEOPLES LIVES ARE BEING PUT AT RISK HERE AND THE TRUTH IS NOT BEING TOLD. ACCORDING TO PT THIS MICROCATHETER IS SOLD TO 13 COUNTRIES WORLD WIDE AND THEY HAVE HAD SERIOUS ISSUES WITH IT IN FRANCE AND GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW MICRO CATHETER KRA MICRO THERAPEUTICS INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L| S