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.This report is associated with mfr report number: 3005168196-2018-01008.The hospital discarded the device.
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The patient was undergoing a coil embolization procedure in the subclavian artery using a lantern delivery microcatheter (lantern) and ruby coils.During the procedure, the physician successfully placed one ruby coil using the lantern.The physician then felt resistance while advancing another ruby coil through the lantern and, consequently, the pusher assembly of the ruby coil became kinked.The physician, therefore, removed the ruby coil and lantern and noticed that the proximal end of the lantern had become kinked near the hub of the non-penumbra catheter.The procedure was completed using a new microcatheter, the same sheath, new ruby coils, and additional coils.There was no report of an adverse effect to the patient.
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