BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    MDR report key: 6122585 · Received November 22, 2016

    Report

    Report Number
    3005099803-2016-03616
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 2, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: AN ULTRAFLEX¿ TRACHEOBRONCHIAL DISTAL RELEASE STENT WAS RECEIVED FOR ANALYSIS; SINCE THE DEVICE WAS RECEIVED DEPLOYED, IT IS NOT POSSIBLE TO CONFIRM THE COMPLAINT BASED ON THE CONDITION OF THE RETURNED DEVICE. IN ADDITION, THE DEVICE SHAFT WAS KINKED. THERE WAS NO ISSUE WITH THE STENT. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. BASED ON THE ANALYSIS, THERE IS NO EVIDENCE THAT THE DEVICE FAILED TO MEET SPECIFICATION PRIOR TO SHIPPING. THE DAMAGES NOTED WITH THE DEVICE WERE CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE DURING ATTEMPTED DEPLOYMENT. THE INVESTIGATION CONCLUDED THAT THE OBSERVED FAILURES ARE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. REPORTED EVENT OF STENT PARTIALLY DEPLOYED. 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 ON (B)(6) 2016 THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE STENT WAS TO BE USED DURING A TRACHEAL BRONCHUS CAROTID STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED RELEASING THE STENT WHEN THE STENT COULD NOT BE FULLY DEPLOYED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING 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. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 29, 2016. THE STENT WAS TO BE USED IN THE BRONCHUS TO TREAT A MALIGNANT STRICTURE. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS BUT WAS DILATED PRIOR TO STENT PLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 2, 2016 THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE STENT WAS TO BE USED DURING A TRACHEAL BRONCHUS CAROTID STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED RELEASING THE STENT WHEN THE STENT COULD NOT BE FULLY DEPLOYED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING 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
    773685 ULTRAFLEX¿ TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564900 18890775

    Patients

    Seq Age Sex Outcome Treatment
    1