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 disposed of the device.
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The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the technologist inadvertently kinked the pusher assembly of a ruby coil while attempting to load the ruby coil in to a lantern delivery microcatheter (lantern).The ruby coil was therefore removed, and the procedure was completed using new ruby coils and the same lantern.There was no report of an adverse effect to the patient.
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