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 intended to be implanted transduodenal to treat the gallbladder during an Endoscopic Ultrasound procedure performed on (b)(6) 2026.During the procedure, the physician reported that the sheath was stiff and did not move smoothly. The procedure was able to be completed by using another of the same device. There were no patient complications reported as a result of this event.

Additional Manufacturer Narrative

Block H6: IMDRF Device Code A0510 captures the reportable event of Sheath Difficult to Retract.Block H11:Investigation Results:With all available information, Boston Scientific Corporation concludes that the reported event of Sheath Difficult to Retract was unable to be confirmed. The complaint device was not returned therefore; product analysis could not be performed. Without proper evaluation of the device, it is unknown if the reported event was due to the technique used during the procedure, anatomical conditions or related to device malfunction.Device History Record Review:It was confirmed that 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:The complaint device was not returned therefore; product analysis could not be performed.Similar Complaint Review:A Similar Complaint Review was completed. There were no emerging trends identified that warrant further action.Investigation Conclusion:Based on all gathered information and the results of the product analysis, the complaint investigation conclusion code of Cause Not Established.