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 in the portal vein using ruby coils.During the procedure, the physician successfully deployed and detached multiple ruby coils using a lantern delivery microcatheter (lantern).The pusher assembly of a ruby coil then became bent as it was being advanced out of its introducer sheath and into the lantern.The ruby coil was therefore removed, and the procedure was completed using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.
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