BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE? II

    MDR report key: 3853597 · Received June 6, 2014

    Report

    Report Number
    3005099803-2014-02104
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 13, 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

    A VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED THAT THERE WERE NO ISSUES. 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. THE REPORTED EVENT OF GAUGE READING INACCURATE WAS CONFIRMED AS THE NEEDLE OF THE PRESSURE GAUGE DID NOT MOVE DURING FUNCTIONAL TESTING. IT IS POSSIBLE THAT THE COMPLAINT UNIT WAS DAMAGED DURING HANDLING OF THE DEVICE. THIS MAY HAVE CAUSED THE INTERNAL MECHANISM OF THE GAUGE TO BECOME DAMAGED. HANDLING DAMAGE IS THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT. 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 SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE INFLATION SYRINGE WAS USED DURING A DILATATION PROCEDURE IN THE ESOPHAGUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, THE GAUGE NEEDLE DID NOT MOVE AS THE BALLOON WAS INFLATED. THE GAUGE WAS READING INACCURATELY. REPORTEDLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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 INFLATION SYRINGE WAS USED DURING A DILATATION PROCEDURE IN THE ESOPHAGUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, THE GAUGE NEEDLE DID NOT MOVE AS THE BALLOON WAS INFLATED. THE GAUGE WAS READING INACCURATELY. REPORTEDLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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
    331486 ALLIANCE? II SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M00550601 0016141062

    Patients

    Seq Age Sex Outcome Treatment
    1