The patient was undergoing a coil embolization procedure in the left femoral vein using a pod packing coil (pod pc), a pod coil, and a lantern delivery microcatheter (lantern).During the procedure, after advancing approximately half of the pod pc in the lantern, the pod pc became stuck.Therefore, the lantern containing the pod pc was removed.The pod pc was then removed from the lantern and the lantern was reinserted into the patient.Afterwards, while advancing the pod coil through the lantern, the physician broke the pusher assembly of the pod coil.It was reported that the embolization coil was still attached to the pusher assembly.Therefore, the lantern containing the pod coil was removed.The procedure was completed using new pod pcs, and the same lantern.There was no report of an adverse effect to the patient.
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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.
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