During the af procedure by (b)(6), when "brocken brough" was performed by inserting an rf needle (boston scientific) using a swartz introducer, it stuck to the posterior wall and caused cardiac tamponade.An echocardiogram confirmed the accumulation of pericardial effusion, and the blood pressure decreased.After that, drainage was performed and the pericardial fluid was removed, and the blood pressure recovered.The occurrence of this event discontinued the procedure.The hospital discarded the reported introducer.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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