BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 16620350 · Received March 27, 2023

    Report

    Report Number
    3005099803-2023-01602
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    March 10, 2023
    Report Date
    June 30, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS B5 AND H6 (DEVICE CODES) HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON JUNE 21, 2023. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF AXIOS STENT PARTIALLY DEPLOYED IN THE BILIARY DUCT. BLOCK H10: THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE RECEIVED FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY EXPANDED AND DEPLOYED. THE DELIVERY SYSTEM WAS INSPECTED, AND NO DAMAGES WERE NOTED ON THE INNER SHEATH. FUNCTIONAL INSPECTION WAS PERFORMED BY SLIDING THE CATHETER LOCK TO THE RIGHT, FOLLOWED BY AN UPWARD AND DOWNWARD MOVEMENT OF THE CATHETER CONTROL HUB. WITHOUT ENCOUNTERING ANY RESISTANCE, THE CATHETER SLIDES THROUGH THE LUER. THE STENT HUB WAS ALSO SHIFTED TO THE SECOND AND FOURTH POSITIONS. NO PROBLEMS WERE NOTICED AS THE CATHETER MOVED FREELY. NO OTHER PROBLEMS WERE NOTED TO THE STENT AND DELIVERY SYSTEM. PRODUCT ANALYSIS DID NOT CONFIRM THE REPORTED DEVICE MALFUNCTION OF STENT PARTIALLY DEPLOYED. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LOCKED TO THE SCOPE. THE IFU STATES, "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." HOWEVER, IT WAS REPORTED THAT THE USER ROTATED THE HANDLE AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION CONCLUDED THAT THERE WAS NO CONFIRMATION OF WHAT THE CUSTOMER REPORTED BECAUSE THE STENT WAS RETURNED COMPLETELY DEPLOYED, AND THE DEVICE MET ALL THE MANUFACTURING REQUIREMENTS, AND IT PASSED THE VISUAL INSPECTION DURING THE PRODUCT ANALYSIS. THEREFORE, REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS NO PROBLEM DETECTED.

    Additional Manufacturer Narrative · 0

    IMDRF DEVICE CODE (B)(4) CAPTURES THE REPORTABLE EVENT OF AXIOS STENT FAILED TO DEPLOY IN THE BILIARY DUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 13, 2023, THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRICALLY TO THE BILIARY DUCT FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE AXIOS STENT'S FIRST FLANGE COULD NOT BE DEPLOYED. THE STENT WAS REMOVED, AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. HOWEVER, THE AXIOS STENT AND DELIVERY SYSTEM INSTRUCTIONS FOR USE STATE "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE INSTRUCTION FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED ON JUNE 21, 2023. IT WAS REPORTED THAT THE FIRST FLANGE OF THE AXIOS STENT COULD BE RELEASED, BUT THERE WERE PROBLEMS ENCOUNTERED WITH THE RELEASE OF THE SECOND FLANGE OF THE AXIOS STENT. THE AXIOS STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRICALLY TO THE BILIARY DUCT FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE AXIOS STENT'S FIRST FLANGE COULD NOT BE DEPLOYED. THE STENT WAS REMOVED, AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. HOWEVER, THE AXIOS STENT AND DELIVERY SYSTEM INSTRUCTIONS FOR USE STATE "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE INSTRUCTION FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739928 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553530 0030562611

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention