BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE¿ II

    MDR report key: 5116403 · Received October 1, 2015

    Report

    Report Number
    3005099803-2015-02758
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 11, 2015
    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

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). A VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED THAT THE NEEDLE OF THE GAUGE WAS AT 0 ATM. THE EXTENSION TUBING COULD BE DISCONNECTED FROM THE DEVICE UPON RECEIPT. A FUNCTIONAL EVALUATION OF THE SYRINGE ASSEMBLY WAS DONE WITH A SAMPLE STOPCOCK AND THE SYRINGE WAS ABLE TO BE PRESSURIZED WITHOUT ANY ISSUES OR LEAKS. THE CAUSE OF THE MALFUNCTION ENCOUNTERED DURING THE PROCEDURE WAS LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE DEVICE. IT IS ALSO PROBABLE THAT THE DEVICE WAS MISHANDLED DURING STORAGE OF THE DEVICE IN THE HOSPITAL OR DURING PREPARATION OF THE DEVICE DURING THE PROCEDURE. THIS COULD HAVE LED TO THE GAUGE RECEIVING A SHOCK CAUSING DAMAGE TO THE INTERNAL MECHANISM OF THE GAUGE WHICH WOULD RESULT IN THE GAUGE NOT OPERATING TO ITS SPECIFICATIONS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU)/PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GAUGE NEEDLE DID NOT MOVE AS THE BALLOON WAS BEING INFLATED, SO THE USE OF THIS DEVICE WAS DISCONTINUED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE II INFLATION SYRINGE. 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
    651513 ALLIANCE¿ II SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M00550601

    Patients

    Seq Age Sex Outcome Treatment
    1