BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    MDR report key: 6130300 · Received November 28, 2016

    Report

    Report Number
    3005099803-2016-03620
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 3, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    UDI-DI
    08714729837855
    PMA / PMN Number
    K121048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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

    INVESTIGATION RESULTS: A FULLY-DEPLOYED ULTRAFLEX TRACHEOBRONCHIAL DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS, AND THE STENT WAS NOT RETURNED. VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THERE WAS NO ISSUE WITH THE DEVICE SHAFT. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED EVENT BASED ON THE CONDITION OF THE RETURNED DEVICE BECAUSE THE DEVICE WAS RETURNED FULLY DEPLOYED AND WITHOUT THE STENT. A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE CAUSE OF THE REPORTED DEPLOYMENT DIFFICULTIES WAS MOST PROBABLY DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2016-03620 AND MANUFACTURER REPORT 3005099803-2016-03621 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 03, 2016 THAT TWO ULTRAFLEX TRACHEOBRONCHIAL STENTS WERE TO BE USED IN THE LUNGS TO TREAT A MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BOTH STENTS WOULD NOT FULLY DEPLOY. THE PARTIALLY DEPLOYED STENTS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. 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 STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2016-03620 AND MANUFACTURER REPORT 3005099803-2016-03621 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 03, 2016 THAT TWO ULTRAFLEX TRACHEOBRONCHIAL STENTS WERE TO BE USED IN THE LUNGS TO TREAT A MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BOTH STENTS WOULD NOT FULLY DEPLOY. THE PARTIALLY DEPLOYED STENTS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779546 ULTRAFLEX¿ TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00576490 18799047 08714729837855

    Patients

    Seq Age Sex Outcome Treatment
    1