Device evaluation: the pipeline braid was returned for evaluation with a catheter.As received, the braid was within the catheter.For further examination, the pipeline was pushed out of the catheter without issue.The pushwire was observed to be bent within the capture coil.The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.The pipeline braid was observed to be fully open with slight fraying on both ends.The coating of the entire pushwire length was examined under a video inspection system for coating integrity.Coating damage was observed approximately 10 to 17cm and 40 to 49cm from the distal tip coil as well as from 9.0cm from the proximal end to the proximal end.Based on the analysis findings and event details, the report of pipeline stuck inside capture coil could not be confirmed.The cause for the reported experience could not be conclusively determined as the returned pipeline braid was observed to be released from the capture coil.It is possible that the damaged braid (fraying at both ends) and kink on the pushwire may have contributed to the reported issue, subsequently preventing the braid from releasing from the capture coil.However, the cause for the damages could not be determined.All products are 100% inspected for damage and irregularities during manufacture.Per our instructions for use (ifu): ¿detachment can be facilitated by slowly rotating the delivery wire in the clockwise direction and/or manipulating the microcatheter by locking down the delivery wire and moving both as a system.If the capture coil tip of the delivery system becomes stuck in the mesh of a delivered ped, rotate the wire clockwise while advancing the wire to try to release it, then slowly pull back on the delivery wire.Never rotate the delivery wire more than 10 full turns.If ped does not open after 10 turns, remove the entire system (microcatheter and ped delivery system together).Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ the coating damage on the proximal end of the pushwire appeared to have been caused by mechanical scraping and abrasion.The torque device and rhv were not returned for evaluation; therefore any contributing factors from the torque device/rhv valve could not be determined.The coating damage on the distal end appeared to be delamination.
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