BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO THERAPEUTICS, INC. HYPERFORM

    MDR report key: 559515 · Received December 10, 2004

    Report

    Report Number
    2029214-2004-00068
    Event Type
    Injury
    Date Received
    December 10, 2004
    Date of Event
    November 11, 2004
    Report Date
    December 10, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    DQT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HYPERFORM 4X7 USED TO SLOW FLOW IN THE N-BCA GLUE EMBOLIZATION OF AN AVM. CATHETER PREPPED, AND INTO 7F GUIDE CATHETER AND 50/50 OMNIPAQUE 240 CONTRAST. DR EXPERIENCED DIFFICULT NAVIGATION IN AND AROUND P-COMM. DR OPTED TO USE AN EXCHANGE 10 EXCHANGE WIRE WITHOUT REMOVING THE CATHETER FROM THE PT VASCULATURE. UPON ATTEMPTING TO DEFLATE BALLOON, DEFLATION WAS UNSUCCESSFUL AND ATTEMPTS WERE MADE TO RETRIEVE THE BALLOON. BALLOON WAS FINALLY RETRIEVED AFTER STROKE TO THE PT. BALLOON NOTICED TO BE DEFLATED UPON REMOVAL FROM PT. PT HAS SINCE RECOVERED WITH MINOR NEUROLOGICAL DEFICIT REMAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO THERAPEUTICS, INC. HYPERFORM OCCLUSION BALLOON CATHETER DQT MICRO THERAPEUTICS, INC. 104-4470 618208

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention