EXCELSIOR SL-10 STRAIGHT 2 TIP 150CM

Additional Manufacturer Narrative

THIS IS 2ND OF 2 MDRS. DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE SUBJECT MICROCATHETER WAS RETURNED WITH A STENT DEPLOYED WITHIN THE LUMEN AT THE PROXIMAL END. THE SUBJECT MICROCATHETER SHAFT WAS KINKED/BENT APPROXIMATELY 15 CM FROM THE PROXIMAL END. THE SUBJECT MICROCATHETER WAS CUT IN ORDER TO REMOVE THE STENT. THERE WAS AN UNKNOWN MATERIAL (POSSIBLY SOME SORT OF TUBING LIKE POLYTETRAFLUOROETHYLENE (PTFE)) PRESENT ON THE STENT. FOR FUNCTIONAL INSPECTION, THE SUBJECT MICROCATHETER SHAFT WAS ABLE TO BE FLUSHED. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE SUBJECT MICROCATHETER SHAFT WHEN INSERTED INTO THE SUBJECT MICROCATHETER HUB. A 0.0158" PATENCY MANDREL WAS ABLE TO BE COMPLETELY ADVANCED THROUGH THE SUBJECT MICROCATHETER, RESISTANCE WAS NOTED AT THE DAMAGED AREAS. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTION FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED DEFECT WAS CONFIRMED BASED ON ANALYSIS OF THE DEVICE. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. IT WAS REPORTED THAT THE STENT BECAME COMPLETELY IMMOBILE AFTER ENTERING ONLY A DOZEN CENTIMETERS INTO THE SUBJECT MICROCATHETER. ATTEMPTS TO WITHDRAW THE STENT ALSO ENCOUNTERED RESISTANCE, FORCING THE PHYSICIAN TO FORCIBLY PULL OUT THE STENT, WHICH RESULTED IN ONLY THE DELIVERY WIRE BEING RETRIEVED. THE PHYSICIAN THEN WITHDREW THE SUBJECT MICROCATHETER AND FOUND THAT THE STENT WAS STUCK INSIDE THE SUBJECT MICROCATHETER APPROXIMATELY 10 CM FROM THE HUB, WITH THE STENT APPEARING TO BE ON THE VERGE OF PROTRUDING THROUGH THE SUBJECT MICROCATHETER WALL (THOUGH IT DID NOT ACTUALLY PUNCTURE IT). DURING ANALYSIS, THE SUBJECT MICROCATHETER WAS RETURNED WITH A STENT DEPLOYED WITHIN THE LUMEN AT THE PROXIMAL END. THE SUBJECT MICROCATHETER SHAFT WAS KINKED/BENT APPROXIMATELY 15 CM FROM THE PROXIMAL END. THE SUBJECT MICROCATHETER WAS CUT IN ORDER TO REMOVE THE STENT. THERE WAS AN UNKNOWN MATERIAL (POSSIBLY SOME SORT OF TUBING LIKE POLYTETRAFLUOROETHYLENE (PTFE)) PRESENT ON THE STENT. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE SUBJECT MICROCATHETER SHAFT WHEN INSERTED INTO THE SUBJECT MICROCATHETER HUB. A 0.0158" PATENCY MANDREL WAS ABLE TO BE COMPLETELY ADVANCED THROUGH THE SUBJECT MICROCATHETER, RESISTANCE WAS NOTED AT THE DAMAGED AREAS. BASED ON A REVIEW OF ALL AVAILABLE INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE IT IS PROBABLE THAT THE SUBJECT MICROCATHETER SHAFT WAS DAMAGED DURING MANIPULATION OF THE DEVICE DURING THE PROCEDURE WHEN RESISTANCE WAS ENCOUNTERED TRANSFERRING THE STENT. IT IS PROBABLE THAT THERE MAY HAVE BEEN MOVEMENT OF THE STENT INTRODUCER SHEATH DURING THE TRANSFER ATTEMPT, CAUSING THE DIFFICULTY TO ADVANCE THE STENT WITHIN THE SUBJECT MICROCATHETER. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED ¿CATHETER SHAFT DEFORMED' AND THE AS REPORTED/AS ANALYSED 'CATHETER JAMMED' AS WELL AS THE AS ANALYSED 'CATHETER SHAFT KINKED/BENT', 'CATHETER SHAFT FRICTION' AND ¿CATHETER PTFE INNER LINING PEELING' AS THESE ISSUES ARE ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.

Description of Event or Problem

IT WAS REPORTED THAT THE STENT WAS STUCK INSIDE THE SUBJECT MICROCATHETER SHAFT APPROXIMATELY 10 CM FROM THE HUB, WITH THE STENT APPEARING TO BE ON THE VERGE OF PROTRUDING THROUGH THE SUBJECT MICROCATHETER WALL. THE WALL OF SUBJECT MICROCATHETER WAS DAMAGE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT SUBJECT MICROCATHETER POLYTETRAFLUOROETHYLENE (PTFE) INNER LINING PEELING. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.