POLARIS? ULTRA

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE INVESTIGATION RESULTS OF STENT SHAFT BREAK. BLOCK H11: THE RETURNED POLARIS ULTRA WAS ANALYZED. DURING THE INSPECTION, IT WAS FOUND THE STENT BLADDER COIL WAS DETACHED NEAR THE SHAFT. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, IT IS POSSIBLE TO CONCLUDE THAT THIS ISSUE COULD BE CAUSED BY OPERATIONAL FACTORS. THE RETRIEVAL LINE MAY BE REMOVED BEFORE PLACEMENT AT THE PHYSICIAN'S DISCRETION. IF THE RETRIEVAL LINE GETS ENTANGLED IN THE BLADDER COIL AND IS REMOVED USING EXCESS FORCE, THE STENT CAN GET "DETACHED/SEPARATED" DURING THE PREPARATION AFFECTING THE PERFORMANCE OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "STENT SHAFT BREAK" WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFITS FOR THE PRODUCT. THEREFORE, AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING A RIGID URETEROSCOPIC LITHOTRIPSY, URETERAL CALCULI PROCEDURE A POLARIS ULTRA URETERAL STENT WAS TO BE USED. AFTER UNPACKING, IT WAS FOUND THAT THE TAIL OF THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED STENT SHAFT BREAK.