BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE

    MDR report key: 1880682 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04544
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K922573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04501 ADDRESSES THE CRE BALLOON DILATATION CATHETER, WHILE MANUFACTURER REPORT #3005099803-2010-04544 ADDRESSES THE ALLIANCE INFLATION SYRINGE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE BALLOON DILATATION CATHETER AND ALLIANCE INFLATION SYSTEM WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATATION PROCEDURE PERFORMED ON A (B)(6) OLD MALE PATIENT ON (B)(6), 2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED WITHIN THE ESOPHAGUS. AT A PRESSURE OF 7PSI AND DIAMETER OF 18MM, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON DILATATION CATHETER, AND THE SAME ALLIANCE HANDLE. IT IS UNKNOWN WHETHER THE SAME ALLIANCE INFLATION SYRINGE WAS USED TO COMPLETE THE PROCEDURE; THEREFORE, IT CANNOT BE CONFIRMED WHETHER THE GAUGE OF THE SYRINGE WAS READING ACCURATELY WHEN THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M00550601

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR ALLIANCE II INFLATION HANDLE (BSC)