It was reported by the caller that during the transseptal puncture the patient developed a pericardial effusion.A pericardiocentesis was performed in which s00cc's was removed the pericardial space.The patient was stabilized and transferred to the cardiac care unit for observation.Additional information was received which clarified that the patient's anatomy might have contributed to the event.Because the septum was thick, it required multiple attempts at cautery before getting across.Physician believed that the needle jumped after getting through.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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