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.The hospital discarded the device.
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The patient was undergoing a coil embolization procedure for a vessel sacrifice in the internal carotid artery (ica) using a lantern delivery microcatheter (lantern).During the procedure, while advancing a lantern into the rotating hemostasis valve (rhv), the hospital staff inadvertently kinked the lantern; therefore, it was removed.The procedure was successfully completed using a new lantern, a penumbra coil 400 (pc400) and a pod4.There was no report of an adverse effect to the patient.
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