It was reported that during a ventricular tachycardia procedure, the diagnostic catheter was placed and a transseptal puncture was attempted twice.The lntracardiac echocardiography {ice) catheter was inserted to attempt the puncture and that is when the effusion was found.They got a full echo and did not think it was a large effusion so they proceeded with the procedure.Post procedure, when the blood pressure dropped more, ice showed a larger effusion.The medical intervention provided was a pericardiocentesis and 400+ ml of fluid were removed.The patient's condition was stable.Additional information received stated that the physician's opinion regarding the cause of the adverse event was that it was procedure-related.It was noted that the injury occurred during transseptal phase, as transseptal puncture was attempted twice using only fluoroscopy.The transseptal puncture was performed with a st.Jude medical brk-1 xs transseptal needle and a stryker reprocessed st.Jude medical agilis large curl sheath (ref#: g408324 lot#: 3461044 sn:(b)(6).(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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