BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE? II

    MDR report key: 4100653 · Received September 19, 2014

    Report

    Report Number
    3005099803-2014-03118
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K922573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF GAUGE READING INACCURATELY. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED THAT THE NEEDLE OF THE GAUGE WAS AT 0. FUNCTIONAL EXAMINATION WAS CARRIED OUT AND WHILE PERFORMING THE SYRINGE GAUGE LEAK TEST, IT WAS NOTED THAT THE NEEDLE OF THE GAUGE DID NOT INCREASE WHILE INCREASING THE PRESSURE. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE OF GAUGE READING INACCURATE WAS CONFIRMED. IN THE CASE OF THIS COMPLAINT IT IS POSSIBLE THAT THE COMPLAINT UNIT GOT DAMAGED DURING HANDLING OF THE DEVICE. THIS FAILURE LIKELY OCCURRED DUE TO THE INTERNAL MECHANISM OF THE GAUGE BECOMING DAMAGED DUE TO HANDLING OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE SYRINGE WAS USED DURING A GASTROINTESTINAL TRACT DILATATION IN THE DUODENUM. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INSERTED INTO THE CHANNEL OF THE SCOPE AND DILATATION WAS STARTED. WHILE INCREASING THE PRESSURE LEVEL, THEY NOTICED THAT THE GAUGE WAS NOT FUNCTIONING AND THE NEEDLE WAS NOT MOVING AT ALL. REPORTEDLY, THE DILATATION WAS CONTINUED SLOWLY AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE SYRINGE WAS USED DURING A GASTROINTESTINAL TRACT DILATATION IN THE DUODENUM. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INSERTED INTO THE CHANNEL OF THE SCOPE AND DILATATION WAS STARTED. WHILE INCREASING THE PRESSURE LEVEL, THEY NOTICED THAT THE GAUGE WAS NOT FUNCTIONING AND THE NEEDLE WAS NOT MOVING AT ALL. REPORTEDLY, THE DILATATION WAS CONTINUED SLOWLY AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582189 ALLIANCE? II SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M00550601 0016852018

    Patients

    Seq Age Sex Outcome Treatment
    1