MERCI BGC 9F X 95CM

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE FOR A PATIENT WITH A RIGHT INTERNAL CAROTID ARTERY THROMBOSIS, THE PHYSICIAN USED A BALLOON GUIDE CATHETER TO ESTABLISH ACCESS AND BLOCK ANTEGRADE FLOOD FLOW IN THE INTERNAL CAROTID ARTERY. THE SUBJECT BALLOON GUIDE CATHETER WAS SUCCESSFULLY DELIVERED TO THE ICA AND POSITIONED. THE PHYSICIAN BEGAN TO INFLATE THE BALLOON GUIDE CATHETER. WHEN 0.6ML OF CONTRAST AGENT WAS INJECTED, CONTRAST AGENT LEAKAGE WAS OBSERVED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.