It was reported that during a watchman procedure to treat atrial fibrillation (a fib) in left atrial appendage (laa), a versacross connect solution was selected for use and perforation happened on the right side of the heart while attempting to go transseptal.There was a baseline trace effusion when we started.Just a normal amount of fluid in the pericardial space.The patient had a lipomatous septum (superiorly) and a large eustachian valve that kept pushing the transseptal system off (watchman fxd double curve and versacross connect).Hence in order to attempt to get and maintain contact with the fossa ovalis, a versacross steerable was opened to try to get transseptal.It made contact with the septum inferiorly and posteriorly on transesophageal echocardiogram (tee) and radio frequency was not applied and hence never crossed the septum.Approximately 10 minutes after inserting the steerable versacross, the patient's pressure dropped and a pericardial effusion was noted on the echo.A drain was placed and patient was taken to the operation room (or) where a sternotomy with a repair and a left atrial appendage ligation was performed.The surgeon noted a 4mm hole in a the transverse sinus between the two atria when he performed the sternotomy.Patient was admitted to hospital beyond standard of care and expected to fully recover.The device is not expected to be returned for analysis as it was disposed.
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