EXCELSIOR SL-10 PRE-SHAPED 45 150CM

Description of Event or Problem

THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT CATHETER PTFE POLYTETRAFLUOROETHYLENE INNER LINING WAS PEELED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

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/MICROSCOPIC INSPECTION, THE SL-10 WAS RETURNED WITH A STENT. THE CATHETER SHAFT WAS KINKED/BENT. THE CATHETER TIP WAS FLAT/CRUSHED. THERE WAS AN UNKNOWN MATERIAL (POSSIBLY SOME SORT OF TUBING LIKE POLYTETRAFLUOROETHYLENE PTFE) PRESENT ON THE STENT. DURING FUNCTIONAL INSPECTION, THE MICROCATHETER SHAFT WAS ABLE TO BE FLUSHED. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE CATHETER SHAFT WHEN INSERTED INTO THE CATHETER HUB. A 0.0158" PATENCY MANDREL WAS ABLE TO BE COMPLETELY ADVANCED THROUGH THE MICROCATHETER, RESISTANCE WAS NOTED AT THE DAMAGED AREAS. THE REPORTED EVENT WAS CONFIRMED DURING DEVICE 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 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. 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 WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT THROUGH THE SUBJECT MICROCATHETER, RESISTANCE WAS ENCOUNTERED, PREVENTING FURTHER DELIVERY OF THE STENT. DURING ANALYSIS, THE SUBJECT CATHETER WAS RETURNED WITH A STENT. THE CATHETER SHAFT WAS KINKED/BENT. THE CATHETER TIP WAS FLAT/CRUSHED. THERE WAS AN UNKNOWN MATERIAL (POSSIBLY SOME SORT OF TUBING LIKE PTFE) PRESENT ON THE STENT. THE MICROCATHETER SHAFT WAS ABLE TO BE FLUSHED. A 0.023" PIN GAUGE WAS VERIFIED TO MEET THE CATHETER SHAFT WHEN INSERTED INTO THE CATHETER HUB. A 0.0158" PATENCY MANDREL WAS ABLE TO BE COMPLETELY ADVANCED THROUGH THE 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 CATHETER 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/AS ANALYZED 'CATHETER SHAFT FRICTION' AND 'CATHETER SHAFT KINKED/BENT' AS WELL AS THE AS ANALYZED 'CATHETER TIP FLAT/CRUSHED' 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.