BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    MDR report key: 477673 · Received August 13, 2003

    Report

    Report Number
    2029214-2003-00029
    Event Type
    Injury
    Date Received
    August 13, 2003
    Date of Event
    July 14, 2003
    Report Date
    July 14, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    MJN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH AN ACUTE MCA STROKE AND AN OCCLUDED RIGHT MCA. THE BALLOON PREPARATION (INCLUDING INFLATION/DEFLATION) WAS UNEVENTFUL. THE BALLOON WAS PLACED ACROSS AN MCA OCCLUSION IN AN ATTEMPT TO EXTRACT CLOT AND RESTORE BLOOD FLOW. UPON COMPLETION OF THE ANGIOPLASTY, THE BALLOON WOULD NOT DEFLATE. THROMBOLYSIS OF THE RIGHT MCA RESULTED IN SOME RECANNULIZATION. THE BALLOON CATHETER WAS CUT AT THE INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERGLIDE OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON MJN MICRO THERAPEUTICS, INC. 104-4113 69976

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention