BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX TRACHEOBRONCHIAL

    MDR report key: 18924833 · Received March 18, 2024

    Report

    Report Number
    3005099803-2024-01004
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    December 22, 2023
    Report Date
    March 18, 2024
    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 E1: THE INITIAL REPORTED FACILITY NAME IS (B)(6) HOSPITAL. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE INVESTIGATION FINDING OF A BROKEN STENT. IMDRF DEVICE CODE A040508 CAPTURES THE REPORTABLE INVESTIGATION FINDING OF AN UNRAVELED STENT MATERIAL. BLOCK H10: THE ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL STENT WAS RETURNED FOR ANALYSIS. THE DELIVERY SYSTEM WAS NOT RECEIVED FOR ANALYSIS. A VISUAL INSPECTION FOUND THAT THE STENT WAS FULLY EXPANDED AND DEPLOYED. ADDITIONALLY, THE STENT WAS FOUND TO BE BROKEN AND UNRAVELED. NO OTHER DAMAGES WERE NOTED WITH THE STENT. PRODUCT ANALYSIS DID NOT CONFIRM THE REPORTED EVENT. THE INVESTIGATION CONCLUDED THAT THE ADDITIONAL INVESTIGATION FINDINGS OF STENT BREAKAGE AND STENT UNRAVELED MATERIAL WERE MOST LIKELY DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, THE HANDLING OF THE DEVICE, AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), WHICH COULD HAVE RESULTED IN THE DAMAGES NOTED IN THE DEVICE. MOREOVER, THE INVESTIGATION DID NOT IDENTIFY ANY EVIDENCE OF THE REPORTED EVENT OF A FAILED STENT DEPLOYMENT. THE DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION, AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE CAUSE IS NO PROBLEM DETECTED.

    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 LUNGS TO TREAT BRONCHIAL STENOSIS DURING AN AIRWAY ANGIOGRAPHY STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED INSIDE THE PATIENT DESPITE PULLING THE STENT DEPLOYMENT SUTURE. THE STENT WAS REMOVED, AND IT STILL COULD NOT BE DEPLOYED AFTER MULTIPLE ATTEMPTS OUTSIDE THE PATIENT. 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 FINDINGS OF STENT BREAKAGE AND STENT UNRAVELED MATERIAL. PLEASE SEE BLOCK H10 FOR THE FULL INVESTIGATION DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376044 ULTRAFLEX TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC CORPORATION M00564870 0029967274

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male