BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23785394 · Received December 11, 2025

    Report

    Report Number
    3005099803-2025-06689
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 10, 2025
    Report Date
    April 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    UDI-DI
    08714729904564
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A07 CAPTURES THE REPORTABLE EVENT OF CAUTERY DELIVERS ENERGY INTERMITTENTLY.

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A07 CAPTURES THE REPORTABLE EVENT OF CAUTERY DELIVERS ENERGY INTERMITTENTLY. BLOCK H11: INVESTIGATION RESULT: WITH THE INFORMATION AVAILABLE, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF INTERMITTENT CAUTERY ENERGY DELIVERY COULD NOT BE CONFIRMED. VISUAL INSPECTION OBSERVED THE STENT HUB WAS IN THE 0TH POSITION OF DEPLOYMENT STEPS. IN ADDITION, IT WAS NOTED THAT THE SHEATH WAS KINKED NEAR THE LUER. NO OTHER DAMAGES OR DEFECTS WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED BY CONNECTING THE CONNECTIVE TUBE TO THE ERBE GENERATOR. BUBBLES WERE OBSERVED IN THE SALINE SOLUTION, INDICATING THAT THE ELECTROCAUTERY TIP WAS FUNCTIONING PROPERLY. REGARDING THE INVESTIGATION FINDINGS, IT WAS MOST LIKELY TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE OR THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), THAT COULD HAVE RESULTED IN THE DAMAGES ENCOUNTERED IN THE DEVICE. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. DEVICE TECHNICAL ANALYSIS: ONE STENT DELIVERY DEVICE WAS RETURNED FOR ANALYSIS. X-RAY IMAGING CONFIRMED THAT THE STENT HAD NOT BEEN DEPLOYED. NO DAMAGE WAS OBSERVED. VISUAL INSPECTION SHOWED THE STENT HUB IN THE 0TH POSITION, AND THE SHEATH WAS FOUND TO BE KINKED NEAR THE LUER. NO ADDITIONAL DEFECTS WERE IDENTIFIED ON THE STENT OR THE REMAINDER OF THE DELIVERY SYSTEM. FUNCTIONAL EVALUATION WAS PERFORMED. THE DEVICE WAS CONNECTED TO THE ERBE GENERATOR, AND BUBBLES WERE OBSERVED IN THE SALINE SOLUTION, INDICATING THAT THE ELECTROCAUTERY TIP WAS FUNCTIONING PROPERLY. A MULTIMETER WAS USED TO MEASURE RESISTANCE ACROSS THE DEVICE'S CLOSED CIRCUIT BY PLACING THE PROBES ON THE MONOPOLAR PLUG AND THE CAUTERY WIRE IN THE NOSE CONE. THE MEASURED RESISTANCE WAS 1.9 OHMS, WHICH IS WITHIN SPECIFICATION LABELING REVIEW: A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. RISK REVIEW: A REVIEW OF THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM DFMEA WAS COMPLETED AND CONFIRMED THAT THE EVENT OF CAUTERY DELIVERS ENERGY INTERMITTENTLY 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 THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE ASSIGNED IS NO PROBLEM DETECTED.

    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 DURING A CHOLECYSTOGASTROSTOMY PROCEDURE PERFORMED APPROXIMATELY BETWEEN (B)(6) 2025. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE CAUTERY LACKED PROPER CURRENT CONDUCTION. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS 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 DURING A CHOLECYSTOGASTROSTOMY PROCEDURE PERFORMED APPROXIMATELY BETWEEN (B)(6) 2025 TO (B)(6) 2025. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE CAUTERY LACKED PROPER CURRENT CONDUCTION. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250015 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553540 08714729904564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention