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A pericardial effusion (pe), leading to cardiac tamponade and hypotension occurred.During a watchman left atrial appendage closure procedure, a versacross connect laac access solution kit was selected for use.It was reported that a transseptal was attempted but failed due to an incomplete non-boston scientific grounding pad connection.The versacross rf wire advanced out of habit during the attempt to deliver radio frequency energy, but the versacross rf wire did not cross the septum.The non-boston scientific grounding pad was reconnected and the placement on patient was double checked, error was resolved.However, on the next attempt to cross, a ground pad error re-appeared.Finally, a new non-boston scientific grounding pad was placed on the opposite leg of the patient and reconnected, transseptal was then completed with no issues.Shortly after, an effusion was seen on the echocardiogram on the left and right ventricles, along with hypotension and a tamponade in the left and right ventricles.The physician opted to move ahead with the procedure and attempted to place of a 27mm watchman device.The pe was then drained by pericardiocentesis, and the physician decided to use a 24mm watchman device instead.Pass criteria was met with this device and it was successfully implanted.The procedure was completed successfully.The patient was then sent to the intensive care unit (icu) for further monitoring of the pericardial drain in a stable condition and later discharged.The device is not expected to be returned for analysis.Prior to the procedure, no pe was noted on echo.The patient was not on warfarin or any antiplatelet drugs at this time.The rf was applied three (3) times before crossing successfully with no excessive force required.The physician does not believe that the devices malfunctioned during the procedure; however, they do believe that one of them have may have indirectly contributed to the adverse event, since the effusion seen on echo shortly after tsp crossing.
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