(b)(4).Please also note that the manufacturer could not determine which lot number corresponded to the pod6 that encountered friction and became ¿stretched¿ and which lot number corresponded to the pod6 that encountered friction, then unintentionally detached.Therefore, the same evaluation codes will be provided on this report and the associated report listed below.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2017-01485.The hospital discarded the device.
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The patient was undergoing a coil embolization procedure in the splenic artery using pod6s.During the procedure, while deploying a pod6 into the splenic artery using a lantern delivery microcatheter (lantern) and a non-penumbra catheter, the patient experienced a spasm in the splenic artery and the pod6 was squeezed out the splenic artery and into the celiac trunk.It was reported that the pod6 had a 180 degree angle with the lantern; consequently, when the physician attempted to retract the pod6, friction was encountered and the pod6 became ¿stretched¿.The physician was able to remove the pod6 out of the lantern.It was noted that after removing the pod6, the spasm resolved on its own.The physician then attempted to deploy a second pod6 in the splenic artery; however, the patient experienced another spasm and the pod6 was pushed out the vessel.The physician then decided to retract the pod6; however, friction was encountered and subsequently, the pod6 unintentionally detached within the lantern.Therefore, the physician removed the non-penumbra catheter and the lantern containing the detached coil all together.It was reported that after the second spasm occurred, the splenic artery remained closed and the physician did not need to implant any coil.Additionally, no medication was administered to release the spasm.The procedure was completed at that point.
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