The product was disposed of by the hospital and is no longer available for return.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 to treat an abdominal aneurysm using ruby coils.During the procedure, the hospital technologist inadvertently bent a ruby coil pusher assembly while attempting to advance it through a lantern delivery microcatheter (lantern); therefore, it was removed.The procedure was completed using additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.
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