Description of Event or Problem · 0
DURING PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED. THE SHEATH WAS INSERTED THROUGH THE RIGHT FEMORAL VEIN, THE NON- (B)(6) CATHETER (ULTRA ICE PLUS BOSTON SCIENTIFIC) WAS FLUSHED AND THEN INSERTED THROUGH THE SHEATH WITHOUT ANY NOTED RESISTANCE. WHEN ASPIRATING BLOOD, AIR WAS ASPIRATED INTO THE SYRINGE. PHYSICIAN FELT THAT THE HEMOSTASIS VALVE WAS LOOSE. THE SHEATH WAS REPLACED WITH ANOTHER OF THE SAME MODEL BUT AIR WAS STILL ASPIRATED. THE NON- (B)(6) CATHETER (ULTRA ICE PLUS BOSTON SCIENTIFIC) WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WAS REMOVED BEFORE THE AIR WAS INTRODUCED INTO THE PATIENT. FLUOROSCOPY WAS USED TO CONFIRM THAT NO AIR ENTERED THE PATIENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).