BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE¿ II

    MDR report key: 3021238 · Received March 26, 2013

    Report

    Report Number
    3005099803-2013-01930
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K922573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). FOR THE REPORTED EVENT OF GAUGE READING INACCURATELY. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-01930 ADDRESSES THE FIRST ALLIANCE SYRINGE, WHILE MANUFACTURER REPORT 3005099803-2013-01931 ADDRESSES THE SECOND ALLIANCE SYRINGE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT TWO ALLIANCE SYRINGES WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE NEEDLE ON THE GAUGE WOULD NOT MOVE. THEY KEPT PRESSING THE SYRINGE AND THE NEEDLE SUBSEQUENTLY JUMPED TO READ A PRESSURE, BUT THE GAUGE WAS READING INACCURATELY. THE DEVICE WAS REMOVED AND ANOTHER SYRINGE WAS USED. HOWEVER THE SAME SITUATION HAPPENED; THE GAUGE WAS READING INACCURATELY. THE SYRINGE WAS REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A THIRD ALLIANCE SYRINGE WITHOUT ANY ISSUES. 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
    124804 ALLIANCE¿ II SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M00550601

    Patients

    Seq Age Sex Outcome Treatment
    1