WATCHMAN FLX DEVICE

Description of Event or Problem

PATIENT HAD A LEFT ATRIAL APPENDAGE OCCLUSION PROCEDURE WITH A WATCHMAN DEVICE. THERE WAS SYSTEMIC AIR EMBOLISM THAT CAUSED BRAIN INJURY AND ULTIMATELY DEATH OF THE PATIENT. AIR EMBOLISM WAS PARTLY DUE TO PATIENT TAKING DEEP BREATH AND SNORING WHILE UNDER MAC DURING THE PROCEDURE. THIS PROCEDURE IS DONE UNDER MAC IN SEVERAL INSTITUTIONS. HOWEVER, ABSENCE OF A HEMOSTATIC VALVE IN THE WATCHMAN SHEATH ALLOWED AIR TO ENTER THE SHEATH (WHEN INTRODUCING PIGTAIL CATHETER AND WATCHMAN FLX DEVICE) AND WAS SUCKED INTO THE LEFT ATRIUM AND THEREBY INTO THE SYSTEMIC CIRCULATION. PRESENCE OF A HEMOSTATIC VALVE WOULD HAVE PREVENTED THIS COMPLICATION.