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It was reported that the patient became hypotensive and experienced a pericardial effusion, leading to cancellation of the procedure.During a pulmonary vein isolation cryoablation procedure to treat atrial fibrillation, a nrg transseptal needle and torflex guiding sheath were selected for use.While gaining access and conscious sedation (local anesthesia), the patient's blood pressure dropped, with a systolic reading of 80mmhg.The procedure was continued.Upon the introduction of ice into the heart, the physician performed a baseline assessment of the pericardium and noted no effusions at baseline.A coronary sinus catheter as well as this polarx were introduced.An electrophysiology study was performed prior to transeptal and was non resultant.Transeptal was completed under intracardiac echo with nrg needle and torflex sheath.The physician successfully crossed, and heparin was administered.The left superior pulmonary vein was wired, and the sheath was exchanged for the polar sheath.When introducing the polar sheath, pressure was needed, and it did 'jump' when crossing the fossa ovalis.The polarxfit balloon was prepped and inserted into the left atrium.During manipulation of the polar map the patient went into atrial fibrillation.The balloon was positioned in the left superior pulmonary vein and ablation was initiated.Isolation of the vein occurred at 47 seconds.The temperature towards the end of the ablation continued to drop until it reached -70 when the physician terminated the ablation at 173 seconds.During this ablation the pressures dropped more to 60mmhg on the readings from the arterial line.At this point the physician checked for effusion on intracardiac echo where there was one apparent around the basal aspect of the left ventricle.At this point the procedure was cancelled, and the physician began a pericardiocentesis.Anesthesia supported the pressure of the patient and heparin reversal was given.Approximately 350cc of blood was removed from the pericardial space.The patient stabilized was extubated and admitted to the hospital.The physician did not note any equipment malfunctions that lead to the effusion.The patient was in stable condition.The device was disposed by the facility and will not be returned as the device performed as expected during the procedure and there were no reports of any performance concerns.There was no difficulty noted with transseptal puncture itself.It was noted that septum was tough and difficult to dilatate with both the polar sheath and the torflex.The physician is not certain which devices may have contributed to the patient complication, but said the most likely explanation was the polar sheath when crossing the intra-atrial septum.
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