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.This report is associated with mfr report number: 3005168196-2018-01577.
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The patient was undergoing a coil embolization procedure in the hypogastric artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, a guidewire was loaded into a lantern and the physician attempted to advance the lantern into the guide catheter through the rotating hemostasis valve (rhv).However, the physician inadvertently kinked the tip of the lantern; therefore, it was removed.The physician then attempted to advance the guidewire into the lantern on the back table but the kink was significant and resistance was encountered with the guidewire.Therefore, the physician opened a new lantern.While loading a ruby coil into the new lantern, the hospital technologist inadvertently kinked the ruby coil pusher assembly; therefore, it was removed.The procedure was completed using a new ruby coil and the same lantern.It should be noted that the physician did not use the peel away sheath with the first lantern.There was no report of an adverse effect to the patient.
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