The pipeline flex pusher was protruding from within the marksman catheter hub for ~59.0cm.The marksman catheter body was found acco rdioned from ~26.7cm to ~23.5cm from the distal tip.In addition, the marksman catheter body was found flattened at ~6.5cm from the distal tip.No damage was found with the marksman distal marker/tip.The marksman catheter total length was measured to be ~158.5cm and the useable length was measured to be ~151.0cm which is within specification (specification: 150cm ± 3cm).The pipeline flex pusher was removed (pulled out) from with the marksman catheter without issue.The distal hypotube with ptfe shrink tubing was found intact.The pusher was found detached at the distal hypotube weld (solder joint).The pipeline flex distal segment (resheathing pad/marker, braid, ptfe sleeves, distal marker, and tip coil) were found detached.The marksman catheter was dissected (cut) and the pipeline flex distal segment found stuck at ~58.5cm from the proximal end of the hub (~100.0cm from distal tip).The pipeline flex distal segment was removed from within the marksman catheter.The resheathing pad and marker were found in good condition.The pipeline flex braid was found deployed on the pushwire.The pipeline flex braid proximal end was found open, but damaged (frayed).It is likely some damage occurred during removal from within the marksman catheter.The pipeline flex braid distal end was found open and in good condition.The ptfe sleeves with restraints were found intact.The tip coil was found detached from the distal core wire.The distal core wire appears to have been broken.The marksman catheter was re-dissected (cut) and the tip coil found stuck at ~6.5cm from the distal tip.The tip coil was removed from within the marksman catheter.The tip coil was found bent.The d etached pushwire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pushwire end shows the presence of tin (sn).The pipeline flex distal pushwire was sent out for sem (scanning electron micrographic) analysis.Per the sem report, the wire end exhibits significant corrosion.No other anomalies were observed.The pipeline flex embolization device and marksman catheter will be retained as per (b)(4).Based on the device analysis and reported information, the customer¿s report of ¿resistance¿ and ¿catheter damage¿ were confirmed.From the damages seen with the pipeline flex (pusher separation) and the marksman catheter (accordioning) it appears excessive force was used.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.In addition, it is likely the damage found with the marksman catheter (flattening) contributed to the resistance.However, the cause for the catheter damage could not be de termined.As the analysis showed presence of soldering material (tin); thereby indicating that the sold ering was conducted.If information is provided in the future, a supplemental report will be issued.
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