CONTOUR

Description of Event or Problem

IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WOULD NOT PASS OVER THE WIRE AND WAS BUCKLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

Additional Manufacturer Narrative

BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL INSIDE THE PATIENT.

Additional Manufacturer Narrative

BLOCK B5 HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED. BLOCK H11: INVESTIGATION ANALYSIS THE DEVICE WAS DISCARDED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF STENT BUCKLED MATERIAL AND STENT/DELIVERY SYSTEM DIFFICULT TO ADVANCE WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.

Description of Event or Problem

IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY. DURING THE PROCEDURE AND OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WOULD NOT PASS OVER THE WIRE AND WAS BUCKLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINANT ON (B)(6) 2026, CLARIFIED THAT THE REPORTED EVENT OF STENT BUCKLED MATERIAL OCCURRED OUTSIDE THE PATIENT. THEREFORE, THIS IS CONSIDERED NON REPORTABLE.