BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    MDR report key: 6202442 · Received December 23, 2016

    Report

    Report Number
    3005099803-2016-03957
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    November 8, 2016
    Report Date
    December 1, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT ONLY THE STENT WAS RECEIVED. THERE WAS NO ISSUE NOTED WITH THE STENT.   BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE DETERMINED; THEREFORE, THE ROOT CAUSE CLASSIFICATION IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 1, 2016 THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE STENT WAS TO BE USED IN THE BRONCHUS TO TREAT A MALIGNANT STRICTURE DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. REPORTEDLY, THE PATIENT¿S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE USING A FLEXIBLE BRONCHOSCOPE, THE PHYSICIAN PLACED A JAGWIRE AND INSERTED THE ULTRAFLEX TRACHEOBRONCHIAL STENT. THE PHYSICIAN STARTED DEPLOYING 50% OF THE STENT WHEN THE CATHETER BOWED TOWARDS THE TRACHEA. THE PHYSICIAN COULD NOT REPOSITION THE STENT BACK TO THE BRONCHUS. THE PARTIALLY DEPLOYED STENT WAS REMOVED AND THE PROCEDURE WAS NOT COMPLETED BECAUSE ANOTHER ULTRAFLEX TRACHEOBRONCHIAL WAS NOT AVAILABLE. REPORTEDLY, THE PATIENT WAS SENT FOR RADIATION THERAPY. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 1, 2016 THAT AN ULTRAFLEX¿ TRACHEOBRONCHIAL DISTAL RELEASE STENT WAS TO BE USED IN THE BRONCHUS TO TREAT A MALIGNANT STRICTURE DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. REPORTEDLY, THE PATIENT¿S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE USING A FLEXIBLE BRONCHOSCOPE, THE PHYSICIAN PLACED A JAGWIRE AND INSERTED THE ULTRAFLEX TRACHEOBRONCHIAL STENT. THE PHYSICIAN STARTED DEPLOYING 50% OF THE STENT WHEN THE CATHETER BOWED TOWARDS THE TRACHEA. THE PHYSICIAN COULD NOT REPOSITION THE STENT BACK TO THE BRONCHUS. THE PARTIALLY DEPLOYED STENT WAS REMOVED AND THE PROCEDURE WAS NOT COMPLETED BECAUSE ANOTHER ULTRAFLEX TRACHEOBRONCHIAL WAS NOT AVAILABLE. REPORTEDLY, THE PATIENT WAS SENT FOR RADIATION THERAPY. 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
    851913 ULTRAFLEX¿ TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564800 0019656603

    Patients

    Seq Age Sex Outcome Treatment
    1