BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX TRACHEOBRONCHIAL

    MDR report key: 18265415 · Received December 5, 2023

    Report

    Report Number
    3005099803-2023-06355
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    August 26, 2023
    Report Date
    December 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A040508 CAPTURES THE REPORTABLE INVESTIGATION FINDING OF STENT UNRAVELED MATERIAL. BLOCK H10: THE ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL STENT AND DELIVERY SYSTEM WERE RECEIVED FOR ANALYSIS. VISUAL INSPECTION FOUND THAT THE STENT WAS FULLY EXPANDED, DEPLOYED FROM THE DELIVERY SYSTEM, AND UNRAVELED. NO OTHER DAMAGES WERE NOTED WITH THE STENT OR THE DELIVERY SYSTEM. PRODUCT ANALYSIS DID NOT CONFIRM THE REPORTED EVENT OF STENT FAILURE TO DEPLOY. THE INVESTIGATION CONCLUDED THAT THE ADDITIONAL INVESTIGATION FINDING OF STENT UNRAVELED MATERIAL WAS MOST LIKELY DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, AND THE TECHNIQUE USED BY THE PHYSICIAN THAT COULD HAVE PREVENTED THE DEPLOYMENT OF THE STENT DURING THE PROCEDURE. HOWEVER, SINCE THE REPORTED EVENT OF STENT FAILURE TO DEPLOY HAPPENED DURING THE PROCEDURE AND THERE WAS NO OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS TO CONFIRM THE REPORTED EVENT, AND THE STENT WAS RETURNED FULLY EXPANDED AND DEPLOYED FROM THE DELIVERY SYSTEM, THIS EVENT COULD NOT BE CONFIRMED. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE CAUSE IS NO PROBLEM DETECTED. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL STENT WAS TO BE IMPLANTED IN THE TRACHEA TO TREAT A TRACHEOESOPHAGEAL FISTULA DURING TRACHEAL STENT IMPLANTATION UNDER A BRONCHOSCOPE FOR A FISTULA BLOCKAGE PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED AT ALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT UNRAVELED MATERIAL. PLEASE SEE BLOCK H10 FOR THE FULL INVESTIGATION DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065262 ULTRAFLEX TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC CORPORATION M00564900 0029199070

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female