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: 3005168196-2018-02530.
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The patient was undergoing a coil embolization procedure in the left ovarian vein using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while attempting to advance a ruby coil through the lantern, the physician experienced resistance.Subsequently, the ruby coil pusher assembly was kinked and the ruby coil unintentionally detached inside the lantern.Therefore, the physician removed the lantern containing the detached coil.It was reported that the lantern became kinked while removing the ruby coil.Therefore, the procedure was completed using a new lantern and a new ruby coil.There was no report of an adverse effect to the patient.
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