BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE? II

    MDR report key: 3903123 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02419
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K922573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER 18 YEARS. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE INFLATION SYRINGE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GAUGE WOULD NOT WORK AND STAYED AT ZERO. THE GAUGE NEEDLE WAS STUCK AND WAS READING INACCURATELY. REPORTEDLY, THIS HAPPENED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380465 ALLIANCE? II SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M00550601 0016833813

    Patients

    Seq Age Sex Outcome Treatment
    1