The clinical observation of pushwire tip separation was confirmed.The pipeline flex delivery system and microcatheter were returned for evaluation without the pipeline as it was implanted in the patient.As received, the pushwire was found to be separated 2.0 cm from the distal tip of the pushwire.The pushwire appeared to be bent 80.0 cm from the proximal end.The detached pushwire was sent out for further sem testing.The sem results were consistent with ductile features that are indicative of overload failure.We are unable to definitively determine the cause of overload failure; however, it is possible that the ¿excessive resistance during delivery and retrieval¿ may have contributed to the reported issues causing the pushwire to become bent and separated.Per the instructions for use (ifu): the user should ¿discontinue delivery of the device if high force or excessive friction is encou ntered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the microcatheter, or the vessel.The lot history record of the reported lot number showed no quality issues against the lot and no other anomalies were found during the document review.All devices are 100% inspected for damage and irregularities during the manufacturing process.Ancillary findings not related this event observed during analysis include coating damage caused by mechanical scraping and abrasion by a metal torque device (pin vise) and/or rhv valve near the distal end of the pushwire.The torque device and rhv were not returned for evaluation; therefore any contributing factors from the torque device/rhv valve could not be determined.(b)(4).
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