AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO PANCREAS DURING A PSEUDOCYST DRAINAGE WITH AXIOS STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6)2024. DURING THE PROCEDURE, THE HANDLE JAMMED AND BROKE AND THE STENT WAS UNABLE TO BE RELEASED. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY. BLOCK H11: FOLLOWING AN UPDATE TO THE AXIOS RISK DOCUMENTATION, THIS EVENT IS BEING REPORTED AS PART OF THE EFFORTS ASSOCIATED WITH BOSTON SCIENTIFIC'S NONCONFORMING EVENTS AND PREVENTION INVESTIGATION, (B)(4). INVESTIGATION RESULTS: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC WAS ABLE TO CONFIRM THE REPORTED EVENT OF STENT FAILURE TO DEPLOY. THE REPORTED EVENT OF HANDLE BREAK COULD NOT BE CONFIRM SINCE THERE WERE NO DAMAGES NOTED ON THE HANDLE. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENTS MAY HAVE BEEN DUE TO THE FAILURE TO FOLLOW THE MANUFACTURER'S INSTRUCTIONS. ACCORDING TO THE EVIDENCE FOUND IN THE PRODUCT ANALYSIS, THE OUTER SHEATH WAS DETACHED AND TWISTED WHICH IS EVIDENCE THAT THE LUER WAS INCORRECTLY ROTATED. IT IS LIKELY THAT FAILURE TO FOLLOW THE MANUFACTURER'S INSTRUCTIONS BY INCORRECTLY ROTATING THE HANDLE, LED TO THE STENT BEING UNABLE TO DEPLOY AND THE HANDLE BREAK. 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 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE RECEIVED FOR ANALYSIS. THE STENT WAS RECEIVED IN AN UNDEPLOYED CONDITION AND FULLY COVERED BY THE OUTER SHEATH. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SHEATH WAS TWISTED IN THE HANDLE SECTION AND DETACHED FROM THE HANDLE. THE HANDLE WAS INSPECTED, AND NO DAMAGE WAS FOUND. NO ADDITIONAL PROBLEM WERE NOTED WITH THE STENT AND DELIVERY SYSTEM. LABELING REVIEW: 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. ACCORDING TO THE EVIDENCE FOUND IN THE PRODUCT ANALYSIS, THE OUTER SHEATH WAS DETACHED AND TWISTED WHICH IS EVIDENCE THAT THE LUER WAS INCORRECTLY ROTATED AS THE IFU STATES ""ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE."" RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE REPORTED EVENTS OF STENT FAILURE TO DEPLOY AND HANDLE BREAK WERE DEFINED IN THE RISK DOCUMENTATION. THESE EVENT TYPES HAVE 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 FAILURE TO FOLLOW INSTRUCTIONS.