Description of Event or Problem · 1
AN EFFUSION WAS OBSERVED DURING A LEFT ATRIAL PROCEDURE. PRIOR TO INTRODUCTION OF THE ARTISAN CATHETER INTO THE PATIENT, THE PHYSICIAN GAINED ACCESS TO THE LEFT ATRIUM WITH A MANUAL TRANSSEPTAL PUNCTURE. THREE TIMES DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ARTISAN CATHETER THROUGH THIS ACCESS POINT. APPROXIMATELY TEN MINUTES AFTER THE ARTISAN CATHETER WAS INTRODUCED INTO THE LEFT ATRIUM FOR THE THIRD TIME, THE PATIENT'S BLOOD PRESSURE DECREASED AND A PERICARDIAL EFFUSION WAS OBSERVED WITH TRANSTHORACIC ULTRASOUND. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS AND THE PATIENT RECOVERED WITH NO FURTHER SEQUELAE. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE. BASED ON PHYSICIAN INPUT, THE DEVICE PERFORMED AS INTENDED. THE PHYSICIAN BELIEVES THAT THE ARTISAN CATHETER MAY HAVE CONTACTED THE ATRIAL APPENDAGE IN CONNECTION WITH CROSSING THE INTRA-ATRIAL SEPTUM, WHICH MAY HAVE BEEN A POSSIBLE CAUSE OF THE EFFUSION.