BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE¿ II

    MDR report key: 5211149 · Received November 9, 2015

    Report

    Report Number
    3005099803-2015-03132
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 21, 2015
    Report Date
    October 22, 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

    A VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED THAT THE NEEDLE OF THE GAUGE WAS AT 0 ATM. A FUNCTIONAL EVALUATION OF THE SYRINGE ASSEMBLY WAS DONE WITH A SAMPLE STOPCOCK AND GAUGE MAINTAINED PRESSURE AT 10 ATM FOR 30 SECONDS. 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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4). 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 AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BALLOON WAS INFLATED USING THE ALLIANCE INFLATION SYRINGE AND AN ALLIANCE HANDLE. HOWEVER, THE GAUGE DID NOT REGISTER A CHANGE IN PRESSURE AS THE BALLOON INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE INFLATION SYRINGE AND THE SAME ALLIANCE HANDLE. 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 AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BALLOON WAS INFLATED USING THE ALLIANCE INFLATION SYRINGE AND AN ALLIANCE HANDLE. HOWEVER, THE GAUGE DID NOT REGISTER A CHANGE IN PRESSURE AS THE BALLOON INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE INFLATION SYRINGE AND THE SAME ALLIANCE HANDLE. 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
    741439 ALLIANCE¿ II SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M00550601

    Patients

    Seq Age Sex Outcome Treatment
    1