BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE¿ II

    MDR report key: 5147104 · Received October 14, 2015

    Report

    Report Number
    3005099803-2015-02855
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 24, 2015
    Report Date
    September 24, 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 GAUGE NEEDLE WAS READING BEYOND 12 ATM. A FUNCTIONAL EVALUATION WAS NOT PERFORMED AS THE EVENT DESCRIPTION HAS BEEN CONFIRMED THROUGH VISUAL ANALYSIS. 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 SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. 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

    (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 A PROCEDURE ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BALLOON WAS INFLATED USING THE ALLIANCE INFLATION SYRINGE AND ALLIANCE HANDLE. THE GAUGE NEEDLE ON THE SYRINGE MOVED TO THE HIGHEST LEVEL; HOWEVER, IT WAS NOT ABLE TO GO BACK TO LOWER READINGS. 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 A PROCEDURE ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BALLOON WAS INFLATED USING THE ALLIANCE INFLATION SYRINGE AND ALLIANCE HANDLE. THE GAUGE NEEDLE ON THE SYRINGE MOVED TO THE HIGHEST LEVEL; HOWEVER, IT WAS NOT ABLE TO GO BACK TO LOWER READINGS. 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
    680018 ALLIANCE¿ II SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M00550601 18049563

    Patients

    Seq Age Sex Outcome Treatment
    1