The patient was undergoing a coil embolization procedure to treat an aneurysm off the posterior communicating artery (pca) using penumbra coils 400 (pc400s), a px slim delivery microcatheter (px slim), and benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician implanted five pc400s via the px slim.While advancing and adjusting the sixth pc400 in and out of the aneurysm to obtain a better position, the physician felt the pc400 break.The physician attempted to remove the pc400, but it was partially broken.Therefore, the broken piece of pc400 was removed together with the px slim and benchmark.The embolization was completed, and the procedure concluded.There was no report of an adverse effect to the patient.
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Evaluation of the returned pc400 confirmed that the pusher assembly was fractured at its distal tip and revealed that the pusher assembly ddt was fractured off and the embolization was detached from the pusher assembly.If the device is forcefully manipulated against resistance during use, the pusher assembly ddt may become fractured off from the distal polymer of the pusher assembly.This damage will likely contribute to the embolization coil detaching from its pusher assembly.Further investigation of the device revealed kinks in the pusher assembly and offset coil winds in the embolization coil.This damage was incidental to the reported complaint may have occurred during packaging of the device for return.Penumbra coils are visually 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.H3 other text : placeholder.
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