Evaluation of the returned pc confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, and the pull wire was in its original position on the distal end of the pusher assembly.If the pc is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and the embolization coil may detach from its pusher assembly.The ovalization on the distal end of the lantern likely contributed to the resistance.The pc embolization coil was detached within the ovalized location of the lantern.Penumbra devices are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a coil embolization procedure in the hypogastric artery using packing coils (pc), a pod coil, a lantern delivery microcatheter (lantern), a non-penumbra catheter (.038), and a guidewire.During the procedure, the lantern was advanced through a non-penumbra catheter into the target location.It was reported that one pod coil was successfully implanted.The physician then attempted to advance a pc through the lantern; however, the lantern kicked back.Upon re-advancing, the lantern would not advance through the non-penumbra catheter.It was noted that the lantern may have been kinked.Therefore, the physician retracted the pc and noticed that the coil had unintentionally detached within the lantern.The lantern was then removed containing the detached pc.After removal, the lantern was noticed to be kinked at the distal end.The lantern was attempted to be flushed; however, the detached pc was stuck at the kinked location and would not flush out.The procedure was completed using a new pc, a non-penumbra microcatheter, and the same non-penumbra catheter.There was no report of an adverse effect to the patient.
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