BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE? II

    MDR report key: 4232871 · Received November 6, 2014

    Report

    Report Number
    3005099803-2014-03523
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    December 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MAV
    PMA / PMN Number
    K922573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER 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 MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED THAT THE NEEDLE OF THE GAUGE WAS AT 0 AND THAT THERE WAS MEDIA IN THE BARREL OF THE DEVICE. FUNCTIONAL EXAMINATION WAS CARRIED OUT AND IT WAS NOTED THAT THE NEEDLE OF THE GAUGE DID NOT INCREASE WHILE INCREASING THE PRESSURE DURING THE SYRINGE GAUGE LEAK TEST. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE OF GAUGE READING INACCURATE WAS CONFIRMED. IN THE CASE OF THIS COMPLAINT IT IS POSSIBLE THAT THE DEVICE TOOK A KNOCK DURING THE PROCEDURE WHICH DAMAGED THE INTERNAL MECHANISM OF THE GAUGE, THUS LEADING TO THE GAUGE NOT READING CORRECTLY. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER 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 A ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SYRINGE WAS INFLATING THE BALLOON, HOWEVER THE NEEDLE ON THE GAUGE REMAINED AT ZERO. 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 FINE.

    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) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SYRINGE WAS INFLATING THE BALLOON, HOWEVER THE NEEDLE ON THE GAUGE REMAINED AT ZERO. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712779 ALLIANCE? II SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - MARLBOROUGH M00550601 17004088

    Patients

    Seq Age Sex Outcome Treatment
    1