ESCAPE

Additional Manufacturer Narrative

BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE INVESTIGATION RESULT OF PULL WIRE DETACHED. BLOCK H11: INVESTIGATION RESULTS: THE RETURNED ESCAPE BASKET WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE HANDLE RETURN IN GOOD CONDITIONS. IT WAS ALSO NOTED THAT THE BASKET RETURNED IN ITS OPEN POSITION. MEDIA ANALYSIS ALSO REVEALED THAT THE BASKET BEING ADVANCED FROM AND RETRACTED INTO THE SHEATH. MICROSCOPIC EXAMINATION WAS PERFORMED UNDER MAGNIFICATION, AND IT WAS NOTICED THAT PULL WIRE DETACHED AND THE HANDLE CANNULA KINKED. FUNCTIONAL EXAMINATION WAS PERFORMED AND WHEN THE HANDLE ACTUATED, THE BASKET FAILED TO OPEN OR CLOSE. ADDITIONALLY. INCREASE RESISTANCE WAS NOTED AND THE HANDLE APPEARED TO BE STUCK. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF WAS CONFIRMED. BASED ON THE ANALYSIS, THE DEVICE MET ALL REQUIRED MANUFACTURING SPECIFICATIONS AND SUCCESSFULLY PASSED ALL APPLICABLE CONTROLS AND INSPECTIONS. NO ABNORMALITIES WERE REPORTED DURING THE ASSEMBLY PROCESS. DURING THE MANUFACTURING PROCESS THERE IS A CONFIRMATION STEP THAT THE SHEATH IS FREE OF KINKS BY RUNNING FINGERS ALONG ITS LENGTH. ALSO, THE HANDLE IS MOVED TO OPEN AND CLOSE POSITION AND IF THE BASKET DOES NOT OPEN AND CLOSE THE DEVICE IS SCRAPPED AS WELL. FINALLY, THERE IS A CONFIRMATION STEP THAT NO BASKET WIRES ARE BROKEN OR KINKED AND IF WIRES ARE BROKEN OR KINKED THE DEVICE IS SCRAPPED. ALL THESE INSPECTIONS ENSURE THE INTEGRITY AND FUNCTIONALITY OF THE DEVICE AND WOULD HAVE CAPTURED THE FAILURES ENCOUNTERED. THE OBSERVED DETACHED AND KINKED OF THE COMPONENTS COULD BE RELATED TO HANDLING, MANIPULATION, ADVANCEMENT THROUGH THE URETEROSCOPE, OR OTHER OPERATIONAL FACTORS ENCOUNTERED DURING THE PROCEDURE. EXCESSIVE FORCE, RESISTANCE, OR INTERACTION WITH PROCEDURAL ACCESSORIES. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION SINCE THE ADVERSE EVENTS OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON THE EVENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN ATTEMPTING TO CLOSE TO CAPTURE THE STONE, THE DEVICE FAILS TO FUNCTION PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS; HOWEVER, INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT THE PULL WIRE DETACHED.