EXCELSIOR SL-10 STRAIGHT 2 TIP 150CM

Description of Event or Problem

THE CATHETER (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE POLY TETRA FLUORO ETHYLENE (PTFE) INNER LINING WAS PEELING. THE CATHETER SHAFT WAS KINKED/BENT, HAD FRICTION AND WAS DIFFICULT TO ADVANCE A GUIDEWIRE THROUGH THE CATHETER. ALSO, THE TIP OF THE CATHETER WAS FOUND TO BE DAMAGED. THE SUBJECT DEVICE WAS REPORTED TO BE REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE CATHETER SHAFT WAS NOTED TO BE KINKED/BENT IN MULTIPLE LOCATIONS. THE CATHETER TIP WAS DAMAGED. THE CATHETER HUB WAS INTACT. DURING FUNCTIONAL INSPECTION THE CATHETER SHAFT WAS FLUSHED WITHOUT ISSUE. A DEMO GUIDEWIRE WAS INSERTED AND COULD NOT ADVANCE PAST 9.2CM FROM THE PROXIMAL END OF THE PROXIMAL OF THE HUB. A 0.0158" PATENCY MANDREL WAS ATTEMPTED TO BE ADVANCED BUT AGAIN COULD NOT BE ADVANCED. THE CATHETER SHAFT WAS SUBMERGED IN WARM WATER. THE PATENCY MANDREL WAS RE-ADVANCED BUT COULD NOT PASS THROUGH. THE SHAFT WAS THEN CUT AT 9.2 CM, AND MATERIAL APPEARING TO BE POLY TETRA FLUORO ETHYLENE (PTFE) WAS REMOVED FROM THE MANDREL. PROCEDURAL FLUID WAS OBSERVED AROUND THE MATERIAL. WHEN PLACED IN WATER, THE PROCEDURAL FLUID DISSOLVED, THE MATERIAL DID NOT DISSOLVE. THE REPORTED EVENT WAS CONFIRMED BASED ON ANALYSIS. THE DEVICE DID NOT MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS 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. IT WAS REPORTED "DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE PHYSICIAN ATTEMPTED TO DELIVER A GUIDEWIRE THROUGH THE SUBJECT MICROCATHETER BUT ENCOUNTERED SIGNIFICANT RESISTANCE DURING ADVANCEMENT. SINCE THE SAME GUIDEWIRE HAD BEEN DELIVERED WITHOUT ISSUE THROUGH AN ECHELON10 MICROCATHETER, THE PHYSICIAN JUDGED THE INITIAL MICROCATHETER TO BE DEFECTIVE. AFTER REPLACING IT WITH ANOTHER MICROCATHETER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.". ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. BASED ON THE REVIEW OF THE AVAILABLE INFORMATION AND ANALYSIS OF THE RETURNED DEVICE, THE PTFE INNER LAYER WAS LIKELY DAMAGED DURING GUIDEWIRE ADVANCEMENT WHEN RESISTANCE WAS ENCOUNTERED. THE OBSERVED EVENT IS CONSIDERED MOST LIKELY ASSOCIATED WITH PROCEDURAL FACTORS DURING USE. THE REPORTED EVENT 'CATHETER DIFFICULTY ADVANCING GUIDEWIRE' AS WELL AS THE ANALYSED EVENT 'CATHETER SHAFT KINKED/BENT', 'CATHETER TIP DAMAGED', 'CATHETER DIFFICULTY ADVANCING GUIDEWIRE', 'CATHETER SHAFT FRICTION', AND 'CATHETER PTFE INNER LINING PEELING' WILL BE ASSIGNED PROCEDURAL FACTORS AS THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL FACTORS DURING USE.