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: 3005168196-2017-01379.The hospital discarded the device.
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The patient was undergoing a coil embolization procedure to treat a complex arm arteriovenous malformation (avm) using a lantern delivery microcatheter (lantern) and ruby coils.It was noted that the patient had a tortuous anatomy.During the procedure, while attempting to advance a ruby coil through the lantern, the physician experienced resistance; therefore, the physician removed the lantern and ruby coil from the patient and was able to advance the ruby coil through the lantern on the scrub trolley.The physician then re-inserted the lantern into the patient¿s body; however, resistance was encountered again and the ruby coil would not advance through the lantern.Therefore, the lantern and ruby coil were removed and the procedure was completed using a non-penumbra microcatheter and additional ruby coils.It was also reported that the lantern may have possibly been placed against the vessel wall and that there did not seem to be any damage to the tip of the lantern after removal.There was no report of an adverse effect to the patient.
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