BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 13345204 · Received January 25, 2022

    Report

    Report Number
    3005099803-2022-00137
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    December 27, 2021
    Report Date
    February 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE PROBLEM ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BLOCK E1 (INITIAL REPORTER PHONE AND INITIAL REPORTER EMAIL) HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022. BLOCK H6: MEDICAL DEVICE PROBLEM CODE A07 CAPTURES THE REPORTABLE EVENT OF CAUTERY DELIVERS ENERGY INTERMITTENTLY. BLOCK H10: A HOT AXIOS STENT AND DELIVERY SYSTEM WERE RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE STENT FULLY COVERED BY THE OUTER SHEATH AND UNDEPLOYED. MICROSCOPIC INSPECTION WAS PERFORMED TO INSPECT THE TIP AND THE MONOPOLAR PLUG; NO DAMAGE WAS FOUND. AN ELECTRICAL TEST WAS PERFORMED TO VERIFY THE CONTINUITY BETWEEN THE RF CONNECTOR AND DISTAL RF ELECTRODE WITH A MULTIMETER; THE RESISTANCE MEASURES WERE 2.1 OHMS, 1.9 OHMS AND 2.0 OHMS. INTERMITTENT ENERGY WAS NOT DETECTED DURING ELECTRICAL INSPECTION. X-RAY ANALYSIS WAS PERFORMED AND THERE WAS NO DAMAGE TO THE COPPER WIRE. NO OTHER ISSUES WITH THE STENT AND DELIVERY SYSTEM WERE NOTED. THE REPORTED EVENT OF CAUTERY DELIVERS ENERGY INTERMITTENTLY COULD NOT BE CONFIRMED; THERE WAS NO INTERMITTENT ENERGY ISSUE NOTED DURING THE ELECTRICAL TEST AND THERE WAS NO DAMAGE NOTED TO THE COPPER WIRE DURING X-RAY ANALYSIS. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE IFU (INSTRUCTIONS FOR USE) / PRODUCT LABEL. THE COMPLAINANT REPORTED THAT THE DEVICE WAS INTENDED TO BE PLACED TRANGASTRIC TO THE JEJUNUM FOR A GASTROJEJUNOSTOMY PROCEDURE. THE IFU STATES, "THE HOT AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH >= 70% FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. " THE HOT AXIOS STENT IS NOT INDICATED TO BE PLACED TRANSGASTRIC TO JEJUNUM. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THERE IS NOT ENOUGH INFORMATION TO CONFIRM THE REPORTED EVENT OF CAUTERY DELIVERS ENERGY INTERMITTENTLY AS THERE WAS NO INTERMITTENT ENERGY ISSUE NOTED DURING THE ELECTRICAL TEST AND THERE WAS NO DAMAGE NOTED TO THE COPPER WIRE DURING X-RAY ANALYSIS. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS NO PROBLEM DETECTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TRANSGASTRIC TO JEJUNUM DURING AN ENDOSCOPIC ULTRASOUND (EUS) - GASTROJEJUNOSTOMY ANASTOMOSIS (GJA) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE AXIOS CAUTERY WAS UNABLE TO CUT THROUGH THE TISSUE; HOWEVER, THERE WAS EVIDENCE OF CAUTERY ON THE TIP AND SLIGHT BLANCHING OF THE TISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT WITH THE SAME ACTIVE CORD, GENERATOR AND GENERATOR SETTINGS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS ATTEMPTED TO BE IMPLANTED FOR A GASTROJEJUNOSTOMY PROCEDURE. HOWEVER, PER THE HOT AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH >= 70% FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED FOR PLACEMENT TRANSGASTRIC TO THE JEJUNUM.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2022 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TRANSGASTRIC TO JEJUNUM DURING AN ENDOSCOPIC ULTRASOUND (EUS) - GASTROJEJUNOSTOMY ANASTOMOSIS (GJA) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE AXIOS CAUTERY WAS UNABLE TO CUT THROUGH THE TISSUE; HOWEVER, THERE WAS EVIDENCE OF CAUTERY ON THE TIP AND SLIGHT BLANCHING OF THE TISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT WITH THE SAME ACTIVE CORD, GENERATOR AND GENERATOR SETTINGS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS ATTEMPTED TO BE IMPLANTED FOR A GASTROJEJUNOSTOMY PROCEDURE. HOWEVER, PER THE HOT AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH >= 70% FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED FOR PLACEMENT TRANSGASTRIC TO THE JEJUNUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743771 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553560 0027088133

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown