BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYPERGLIDE OCCLUSION BALLOON

    MDR report key: 514496 · Received March 4, 2004

    Report

    Report Number
    2029214-2004-00008
    Event Type
    Death
    Date Received
    March 4, 2004
    Date of Event
    January 30, 2004
    Report Date
    March 4, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TO "TACK UP" A COIL LOOP PROTRUDING FROM THE ANEURYSM NECK INTO THE PARENT ARTERY USING THE BALLOON CATHETER. WHILE ATTEMPTING TO PUSH THE COIL LOOP INTO THE COILED ANEURYSM WITH THE INFLATED BALLOON, PHYSICIAN WAS UNABLE TO DEFLATE. PHYSICIAN SWITCHED TO A LARGE SYRINGE, UNSUCCESSFUL AFTER MULTIPLE ATTEMPTS. THE BALLOON'S GUIDEWIRE WAS RETRACTED FROM THE DISTAL APERTURE IN AN ATTEMPT TO DEFLATE THE BALLOON, UNSUCCESSFULLY. THE GUIDEWIRE WAS RE-INSERTED, DEFLATION RE-ATTEMPTED WITHOUT SUCCESS. A NEW GUIDEWIRE WAS INSERTED, DEFLATION PROCEDURE REPEATED, WITHOUT SUCCESS. PHYSICIAN OPTED TO ATTEMPT BALLOON REMOVAL WITH GENTLE TRACTION. FIFTEEN MINUTES LATER, THE BALLOON CATHETER WAS REMOVED FROM THE PT. THE PT DEVELOPED A MASSIVE BLEED FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death