BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23772152 · Received December 10, 2025

    Report

    Report Number
    3005099803-2025-06611
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 17, 2025
    Report Date
    March 5, 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 A150208 CAPTURES THE REPORTABLE EVENT OF SECOND FLANGE STUCK IN SCOPE. BLOCK H11: INVESTIGATION RESULTS: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC COULD NOT CONFIRM THE REPORTED EVENT OF STENT SECOND FLANGE STUCK IN SCOPE AS THE AXIOS STENT WAS NOT RETURNED FOR ANALYSIS, ONLY THE ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS. THERE IS NOT ENOUGH EVIDENCE TO DETERMINE IF THE REPORTED EVENT WAS DUE TO THE PHYSICIAN'S DEVICE MANIPULATION DURING THE PROCEDURE, OR WHETHER IT WAS RELATED TO A DEVICE MALFUNCTION. THE INVESTIGATION CONCLUDED THAT THE ADDITIONAL OBSERVED DAMAGE OF INNER SHEATH KINKED WAS LIKELY CAUSED BY FACTORS ENCOUNTERED DURING THE PROCEDURE, SUCH AS EXCESSIVE FORCE OR THE MANNER IN WHICH THE DEVICE WAS HANDLED AND MANIPULATED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS: AN ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS; THE STENT WAS NOT RETURNED. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE INNER SHEATH KINKED. FUNCTIONAL INSPECTION WAS PERFORMED, THE CATHETER WAS FREELY MOVED THROUGH THE LUER, AND THE SLIDER COULD BE MOVED BACK TO ITS ORIGINAL POSITION WITHOUT RESISTANCE. NO OTHER DAMAGES WERE NOTED TO THE DELIVERY SYSTEM. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE REPORTED EVENT OF STENT SECOND FLANGE STUCK IN SCOPE WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF SECOND FLANGE STUCK IN SCOPE.

    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 TRANSDUODENAL TO GALLBLADDER DURING AN ENDOSCOPIC ULTRASOUND (EUS) GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED BUT THE SECOND FLANGE DID NOT RELEASE FROM THE SCOPE. THE STENT WAS REMOVED TOGETHER WITH THE SCOPE. THE PROCEDURE WAS NOT COMPLETED. 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 TRANSDUODENAL TO GALLBLADDER DURING AN ENDOSCOPIC ULTRASOUND (EUS) GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED BUT THE SECOND FLANGE DID NOT RELEASE FROM THE SCOPE. THE STENT WAS REMOVED TOGETHER WITH THE SCOPE. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2167939 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM QXH BOSTON SCIENTIFIC CORPORATION M00553540 0036804370 08714729904564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown