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 using ruby coils.During the procedure, while attempting to advance a ruby coil through another manufacturer¿s microcatheter, the physician experienced resistance and subsequently, the ruby coil pusher assembly became bent.Therefore, it was removed.The procedure was successfully completed using three additional coils and the same microcatheter.There was no report of an adverse effect to the patient.
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