A case of right ventricular outflow tract (rvot) perforation was reported in a procedure where the nykanen rf wire kit was used on a patient with pulmonary atresia with intact ventricular septum (pa/ivs).The nykanen rf wire was delivered via right femoral access to the target puncture site using a 4fr judkins curve angiographic catheter and a masters microcatheter (asahi intech).The position of the nykanen rf wire was confirmed on fluoroscopy bilaterally.Rf energy was delivered and resulted in perforation of rvot.The procedure was aborted, and open chest surgery was performed where it was confirmed the tip of the rf wire was located inside the pericardium.The perforation did not lead to cardiac tamponade, with only slight changes in the patient's vital signs.After repair of the perforation site and removal of the rf wire, the patient showed minimal bleeding.The patient was moved to icu where the blood pressure dropped and the patient had to undergo extracorporeal membrane oxygenation.The patient remained in icu as of (b)(6) 2022.The physician indicated there were no notable characteristics associated with the patient's anatomy.The physician did not encounter challenge determining the puncture site.As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.
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