PERCUFLEX PLUS

Additional Manufacturer Narrative

BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. BLOCK H6: DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK. BLOCK H11: INVESTIGATION ANALYSIS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; 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 SHAFT BREAK WAS 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 PERCUFLEX PLUS URETERAL STENT WAS USED IN A FLEXIBLE LITHOTRIPSY PROCEDURE. DURING INSERTION AND OUTSIDE THE PATIENT, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.