BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE¿ II

    MDR report key: 5052807 · Received September 3, 2015

    Report

    Report Number
    3005099803-2015-02479
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 7, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K922573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE COMPLAINT DEVICE WAS PERFORMED AND THERE WERE NO ISSUES NOTED. A FUNCTIONAL TEST WAS PERFORMED AND FOUND THAT THE GAUGE NEEDLE WAS ABLE TO MAINTAIN PRESSURE AT 10 ATM FOR 30 SECONDS AND NO LEAKS WERE NOTED. THE EXTENSION TUBE WAS ABLE TO BE SUCCESSFULLY DETACHED AND REATTACHED AND THERE WAS NO ISSUES NOTED TO THE LUER. 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. HOWEVER, 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 LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU)/PRODUCT LABEL.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2015-02479 ADDRESSES THE ALLIANCE SYRINGE AND MANUFACTURER REPORT # 3005099803-2015-02548 ADDRESSES THE CRE BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE AND A CRE BALLOON WERE WAS USED FOR DILATATION OF THE ESOPHAGUS ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE AND THE NEEDLE OF THE SYRINGE WAS READING INACCURATELY. IT WAS ALSO NOTED THAT THE EXTENSION TUBING FROM THE SYRINGE WOULD NOT UNSCREW. THE SYRINGE AND THE BALLOON WERE EXCHANGED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2015-02479 ADDRESSES THE ALLIANCE SYRINGE AND MANUFACTURER REPORT # 3005099803-2015-02548 ADDRESSES THE CRE BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE AND A CRE BALLOON WERE WAS USED FOR DILATATION OF THE ESOPHAGUS ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE AND THE NEEDLE OF THE SYRINGE WAS READING INACCURATELY. IT WAS ALSO NOTED THAT THE EXTENSION TUBING FROM THE SYRINGE WOULD NOT UNSCREW. THE SYRINGE AND THE BALLOON WERE EXCHANGED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584257 ALLIANCE¿ II SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M00550601 17542803

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR