EXCELSIOR SL-10 STRAIGHT 2 TIP 150CM

Description of Event or Problem

THE SUBJECT MICROCATHETER WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THERE WAS AN UNKNOWN MATERIAL PRESENT ON THE STENT AND POSSIBLY IT MIGHT BE SOME SORT OF TUBING LIKE POLYTETRAFLUOROETHYLENE (PTFE) FROM THE SUBJECT MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Additional Manufacturer Narrative

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 CATHETER WAS RETURNED WITH A STENT DEPLOYED APPROXIMATELY 4CM FROM THE PROXIMAL END OF THE MICROCATHETER. THE CATHETER SHAFT WAS KINKED/BENT. THE CATHETER WAS CUT IN ORDER TO RETRIEVE THE STENT. THE CATHETER WAS UNABLE TO BE FLUSHED, BLOOD WAS PRESENT WITHIN THE DEVICE, WHICH WAS REMOVED AS A 0.0158" PATENCY MANDREL WAS ATTEMPTED TO BE ADVANCED THROUGH THE SHAFT. THERE WAS AN UNKNOWN MATERIAL (POSSIBLY SOME SORT OF TUBING LIKE POLYTETRAFLUOROETHYLENE (PTFE) PRESENT ON THE DISTAL END OF THE STENT. DURING FUNCTIONAL INSPECTION, A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE CATHETER SHAFT WHEN INSERTED INTO THE CATHETER HUB. A 0.0158" PATENCY MANDREL WAS UNABLE TO BE COMPLETELY ADVANCED THROUGH THE MICROCATHETER. 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. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE, THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO OPENING THE PACKAGING, THE DEVICE CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT AND CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. IT WAS REPORTED THAT ONE OF THE STENTS GOT STUCK WITHIN THE SUBJECT MICROCATHETER. THE FIRST STENT WAS RETRACTED AND REPLACED WITH A SECOND SUBJECT STENT; HOWEVER, THIS STENT GOT STUCK IN THE SHAFT AND A PART OF THE STENT GOT PREMATURELY DEPLOYED WITHIN THE MICROCATHETER HUB. DURING ANALYSIS, THE SUBJECT MICROCATHETER WAS RETURNED WITH A STENT DEPLOYED APPROXIMATELY 4CM FROM THE PROXIMAL END OF THE MICROCATHETER. THE CATHETER SHAFT WAS KINKED/BENT. THE CATHETER WAS CUT IN ORDER TO RETRIEVE THE STENT. THE CATHETER WAS UNABLE TO BE FLUSHED, BLOOD WAS PRESENT WITHIN THE DEVICE, WHICH WAS REMOVED AS A 0.0158" PATENCY MANDREL WAS ATTEMPTED TO BE ADVANCED THROUGH THE SHAFT. THERE WAS AN UNKNOWN MATERIAL (POSSIBLY SOME SORT OF TUBING LIKE PTFE) PRESENT ON THE DISTAL END OF THE STENT. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE CATHETER SHAFT WHEN INSERTED INTO THE CATHETER HUB. A 0.0158" PATENCY MANDREL WAS UNABLE TO BE COMPLETELY ADVANCED THROUGH THE MICROCATHETER. BASED ON A REVIEW OF ALL AVAILABLE INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE IT IS PROBABLE THAT THERE MAY HAVE BEEN AN ISSUE WITH THE FLUSH DURING THE PROCEDURE DUE TO THE PRESENCE OF BLOOD IN THE CATHETER, CAUSING THE STENT TO HAVE DIFFICULTY ADVANCING IN THE MICROCATHETER. THE CATHETER SHAFT WAS MOST LIKELY DAMAGED DURING MANIPULATION OF THE DEVICE WHEN THE RESISTANCE WAS ENCOUNTERED. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED/AS ANALYSED 'CATHETER SHAFT FRICTION' AS WELL AS THE AS ANALYSED 'CATHETER SHAFT KINKED/BENT', 'DEVICE DIFFICULT TO FLUSH', 'CATHETER SHAFT BLOCKED/OCCLUDED' 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.