PERCUFLEX URINARY DIVERSION STENT

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: DEVICE CODE A0401 CAPTURES THE REPORTABLE INVESTIGATION FINDING OF STENT SHAFT BREAK. BLOCK H11: INVESTIGATION ANALYSIS: UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS URINARY DIVERSION STENT UNDERWENT A THOROUGH ANALYSIS. VISUAL ANALYSIS IDENTIFIED THAT THE COIL WAS KINKED IN ONE SECTION AND THE STENT SHAFT WAS DETACHED. 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 KINKED AND STENT DETACHED WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFITS FOR THE PRODUCT. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, 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 OR RENAL COIL) AND IS REMOVED USING EXCESS FORCE, THE STENT CAN GET DETACHED/SEPARATED (OR TORN) DURING THE PREPARATION AFFECTING THE PERFORMANCE OF THE DEVICE. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNINTENDED USE ERROR CAUSE OR CONTRIBUTED TO EVENT.

Description of Event or Problem

IT WAS REPORTED THAT A URINARY DIVERSION STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE PIGTAIL PART WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT SHAFT BREAK. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.