BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23610226 · Received November 20, 2025

    Report

    Report Number
    3005099803-2025-06064
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 27, 2025
    Report Date
    March 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QXH
    UDI-DI
    08714729904564
    PMA / PMN Number
    K150692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. IMDRF DEVICE CODE A0510 CAPTURES THE REPORTABLE EVENT OF DELIVERY SYSTEM RETRACTION PROBLEM. BLOCK H11: INVESTIGATION SUMMARY: WITH ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDED THAT THE REPORTED EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND AND DELIVERY SYSTEM RETRACTION PROBLEM COULD NOT BE CONFIRMED, THE STENT WAS RETURNED FULLY EXPANDED AND DEPLOYED AND NO ISSUES WERE FOUND DURING FUNCTIONAL INSPECTION OF THE DELIVERY SYSTEM. THE INVESTIGATION CONCLUDED THAT THERE IS NOT ENOUGH EVIDENCE TO DETERMINE IF THE REPORTED EVENTS WERE DUE TO THE PHYSICIAN'S DEVICE MANIPULATION DURING THE PROCEDURE OR RELATED TO A DEVICE MALFUNCTION. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS: AN AXIOS STENT WITH ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY EXPANDED AND DEPLOYED. THE HANDLE WAS INSPECTED AND NO ISSUES WERE FOUND. FUNCTIONAL INSPECTION WAS PERFORMED, THE CATHETER WAS FREELY MOVED THROUGH THE LUER AND THE SLIDER COULD BE MOVED TO ITS ORIGINAL POSITION WITHOUT RESISTANCE. NO PROBLEMS WERE NOTED WITH THE STENT OR THE DELIVERY SYSTEM. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF "STENT FIRST FLANGE FAILURE TO EXPAND AND DELIVERY SYSTEM RETRACTION PROBLEM" WERE DEFINED IN THE RISK DOCUMENTATION AND ARE DOCUMENTED ACCORDINGLY IN THE PRR. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE OVERALL ROOT CAUSE OF THE REPORTED EVENTS IS UNABLE TO EXCLUDE DEVICE PROBLEM.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. IMDRF DEVICE CODE A0510 CAPTURES THE REPORTABLE EVENT OF DELIVERY SYSTEM RETRACTION PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE GALLBLADDER DURING DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE CATHETER FELT VERY STIFF AND UNCOMFORTABLE WHEN UNFOLDING THE FLANGE. IT WAS OBSERVED THAT THE FLANGE SHAPE WAS NOT NORMAL, AND STENT DEPLOYMENT COULD NOT BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE GALLBLADDER DURING DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE CATHETER FELT VERY STIFF AND UNCOMFORTABLE WHEN UNFOLDING THE FLANGE. IT WAS OBSERVED THAT THE FLANGE SHAPE WAS NOT NORMAL, AND STENT DEPLOYMENT COULD NOT BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584912 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM QXH BOSTON SCIENTIFIC CORPORATION M00553540 0036353060 08714729904564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown