BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE? II

    MDR report key: 3182878 · Received June 21, 2013

    Report

    Report Number
    3005099803-2013-05682
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MAV
    PMA / PMN Number
    K922573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT WAS OVER 18 YEARS OLD. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITH EXTENSION TUBING. VISUAL EXAMINATION OF THE DEVICE NOTED THE GAUGE NEEDLE WAS BELOW ZERO ATMS. FUNCTIONAL TESTING WAS PERFORMED; THE DEVICE WAS PREPPED WITH 35ML OF WATER AND WAS PRESSURIZED TO 12ATM FOR 30 SECONDS; HOWEVER, THE GAUGE NEEDLE DID NOT MOVE. THE COMPLAINT EVENT DESCRIPTION WAS CONFIRMED. IT IS LIKELY THE DEVICE WAS MISHANDLED DURING STORAGE OR PREPARATION OF THE DEVICE, WHICH COULD HAVE LED TO THE GAUGE RECEIVING A SHOCK CAUSING DAMAGE TO THE INTERNAL MECHANISM OF THE GAUGE, AND RESULTING IN THE GAUGE NOT OPERATING TO ITS SPECIFICATIONS. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS HANDLING DAMAGE. THE DEVICE HISTORY RECORD REVIEW CONFIRMS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE INFLATION SYRINGE WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE PHYSICIAN ATTEMPTED TO PERFORM DILATATION THE PRESSURE WOULD NOT INCREASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE 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. PRELIMINARY EVALUATION OF THE DEVICE REVEALED THE GAUGE NEEDLE TO BE STUCK AND READING INACCURATELY; THEREFORE, THIS HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE INFLATION SYRINGE WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE PHYSICIAN ATTEMPTED TO PERFORM DILATATION THE PRESSURE WOULD NOT INCREASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE 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. PRELIMINARY EVALUATION OF THE DEVICE REVEALED THE GAUGE NEEDLE TO BE STUCK AND READING INACCURATELY; THEREFORE, THIS HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282731 ALLIANCE? II SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - MARLBOROUGH M00550601 15967951

    Patients

    Seq Age Sex Outcome Treatment
    1