UTS PRECURVED ULTRA TAPER SPHINCTEROTOME

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT OF INCORRECT CUTTING WIRE ORIENTATION. DURING THE LABORATORY ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 4 O'CLOCK (APPROPRIATE ORIENTATION IS APPROXIMATELY 11:00 - 1:00 O'CLOCK). THE DEVICE WAS UNABLE TO BE BOWED DURING FUNCTIONAL TESTING. FURTHER EXAMINATION OF THE DEVICE FOUND THE CENTER CANNULA IS BROKEN, APPROXIMATELY 20 CM FROM THE DISTAL END OF THE DEVICE. THE BREAK IN THE CANNULA REMAINS ENCLOSED IN THE OUTER TUBING OF THE DEVICE AND NO PIECE IS MISSING. A BREAK IN THE CENTER CANNULA CAN OCCUR IF EXCESSIVE PRESSURE IS APPLIED TO THE DEVICE IF ORIENTATION ISSUES ARE ENCOUNTERED. THE SPHINCTEROTOME CATHETER WAS SUBJECTED TO A CLOSE VISUAL EXAMINATION AND TWISTING OF THE TUBING WAS NOT OBSERVED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS OBSERVATION WAS NOT FOUND DURING OUR LABORATORY ANALYSIS OF THE RETUNED PRODUCT. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THE LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. IMPROPER CUTTING WIRE ORIENTATION CAN OCCUR IF THE DISTAL END OF THE CATHETER IS SHAPED MANUALLY. THIS SPHINCTEROTOME CATHETER IS PRE-CURVED AND IS PROVIDED WITH A PRE-CURVED STYLET IN THE DISTAL TIP OF THE CATHETER. THIS OBVIATES THE NEED FOR MANUAL FORMATION. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT APPLY MANUAL PRESSURE TO TIP OR CUTTING WIRE OF THE SPHINCTEROTOME TO INFLUENCE ORIENTATION, AS THIS MAY RESULT IN DAMAGE TO DEVICE." OTHER FACTORS THAT CAN CONTRIBUTE TO IMPROPER CUTTING WIRE ORIENTATION INCLUDE MANIPULATING THE HANDLE WITH THE CATHETER IN COILED POSITION OR WITH THE PRECURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE ADVISE THE USER TO UNCOIL AND STRAIGHTEN THE SPHINCTEROTOME UPON REMOVING THE DEVICE FROM THE PACKAGING. THE USER IS THEN INSTRUCTED TO CAREFULLY REMOVE THE PRECURVES STYLET FROM THE CANNULATING TIP. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRECURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO SPHINCTEROTOME AND RENDER IT INOPERABLE." SEPARATION OF THE DRIVE WIRE FROM THE CUTTING WIRE CAN OCCUR IF THE TIP OF THE DEVICE IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE THE SPHINCTEROTOME. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT THE ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING THE SPHINCTEROTOME. IF THE ELEVATOR OF THE ENDOSCOPE IS PLACED IN THE CLOSED/UP POSITION WITH THE SPHINCTEROTOME INSIDE THE ACCESSORY CHANNEL, THIS COULD CONSTRICT MOVEMENT OF THE DEVICE WIRE WHEN THE HANDLE IS MANIPULATED IN AN ATTEMPT TO BOW THE SPHINCTEROTOME. IF ADDED PRESSURE IS APPLIED TO THE HANDLE WITH THE ELEVATOR AND SPHINCTEROTOME IN THIS POSITION, THIS COULD CONTRIBUTE TO DRIVE WIRE SEPARATION FROM THE CUTTING WIRE. PRIOR TO DISTRIBUTION, ALL UTS PRECURVED ULTRA TAPER SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

Description of Event or Problem

DURING AN ENDOSCOPE RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME WAS USED. THE WIRE BOWED THE CATHETER TIP IN THE OPPOSITE DIRECTION (INCORRECT CUTTING WIRE ORIENTATION). THE DEVICE WAS REMOVED AND THE PHYSICIAN USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.