EXCELSIOR XT-17 FLEX STRAIGHT 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. THE SUBJECT MICROCATHETER SHAFT WAS FLAT/CRUSHED, AT THE DISTAL END. THE SUBJECT MICROCATHETER WAS CUT IN ORDER TO RETRIEVE THE STENT. THERE WAS AN UNKNOWN MATERIAL (POSSIBLY SOME SORT OF TUBING LIKE POLYTETRAFLUOROETHYLENE (PTFE)) PRESENT ON THE STENT. DURING FUNCTIONAL INSPECTION, THE SUBJECT MICROCATHETER SHAFT WAS UNABLE TO BE FLUSHED. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE CATHETER SHAFT WHEN INSERTED INTO THE CATHETER HUB. A 0.0160" PATENCY MANDREL WAS UNABLE TO BE ADVANCED THROUGH THE FLAT/CRUSHED SECTION THE DISTAL END. 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 PHYSICIAN ATTEMPTED TO DEPLOY A STENT THROUGH THE SUBJECT MICROCATHETER. HOWEVER, WHEN THE STENT HAD ENTERED APPROXIMATELY 2 CM INTO THE SUBJECT MICROCATHETER HUB, THE ASSISTANT WAS UNABLE TO CONTINUE ADVANCING IT, AND REPEATED ATTEMPTS BY THE PHYSICIAN ALSO FAILED. THE DELIVERY WIRE FOR THE STENT WAS THEN WITHDRAWN, RESULTING IN STENT DEPLOYMENT AND ENTRAPMENT WITHIN THE SUBJECT MICROCATHETER. DURING ANALYSIS, THE SUBJECT MICROCATHETER WAS RETURNED WITH A STENT DEPLOYED WITHIN THE LUMEN. THE SUBJECT MICROCATHETER SHAFT WAS FLAT/CRUSHED, AT THE DISTAL END. THE SUBJECT MICROCATHETER WAS CUT IN ORDER TO RETRIEVE THE STENT. THERE WAS AN UNKNOWN MATERIAL (POSSIBLY SOME SORT OF TUBING LIKE POLYTETRAFLUOROETHYLENE (PTFE)) PRESENT ON THE STENT. THE SUBJECT MICROCATHETER SHAFT WAS UNABLE TO BE FLUSHED. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE MICROCATHETER SHAFT WHEN INSERTED INTO THE CATHETER HUB. A 0.0160" PATENCY MANDREL WAS UNABLE TO BE ADVANCED THROUGH THE FLAT/CRUSHED SECTION THE DISTAL END. 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 TRANSFER THE STENT. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED ¿CATHETER HUB FRICTION' AS WELL AS THE AS ANALYSED 'CATHETER SHAFT FRICTION', 'CATHETER SHAFT FLAT/CRUSHED', 'CATHETER PTFE INNER LINING PEELING' AND 'DEVICE DIFFICULT TO FLUSH' 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 SUBJECT MICROCATHETER ENCOUNTERED RESISTANCE WHILE TRANSFERRING THE STENT THROUGH IT. 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 THE SUBJECT MICROCATHETER HAD POLYTETRAFLUOROETHYLENE (PTFE) INNER LINING PEELING. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.