BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUSION BALLON CATHETER

    MDR report key: 1230451 · Received November 7, 2008

    Report

    Report Number
    3005099803-2008-06155
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    PMA / PMN Number
    K841941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED BOTH PROXIMAL AND DISTAL BALLOON BONDS WERE INTACT AND CONTINUOUS. THE BALLOON WAS OBSERVED TO BE BURST IN THE MIDSECTION. IN ADDITION, FURTHER ANALYSIS FOUND THE DEVICE WAS USED IN THE PROCEDURE AFTER IT'S EXPIRATION DATE OF JUNE 30, 2008. THE DFU FOR THIS PRODUCT INCLUDES THE FOLLOWING INSTRUCTIONS; PRIOR TO USE, CAREFULLY EXAMINE THE UNIT TO VERIFY THAT THE STERILE PACKAGE OR PRODUCT HAS NOT BEEN DAMAGED IN SHIPMENT. PRIOR TO INTRODUCTION, TEST THE BALLOON TO DETERMINE THE AMOUNT OF FLUID NECESSARY TO INFLATE TO BALLOON TO THE DESIRED INFLATION. FAILURE TO DO SO MAY RESULT IN BALLOON RUPTURE OR URETERAL RUPTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUSION BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER "BALLOON" WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUSION BALLOON CATHETER. NO PT COMPLICATION WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCCLUSION BALLON CATHETER KOD BOSTON SCIENTIFIC CORPORATION M0062201070 9310578

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK