COR-KNOT MINI®

Description of Event or Problem

PATIENT WAS DIAGNOSED TO HAVE SEVERE AORTIC VALVE STENOSIS. CARDIAC CATHETERIZATION WAS ALSO THEN PERFORMED WHICH REVEALED NONOBSTRUCTIVE CORONARY ARTERY DISEASE. PATIENT IS NOW REFERRED FOR POSSIBLE AORTIC VALVE INTERVENTION. PATIENT WAS IN THE SURGICAL SUITE FOR AN AORTIC VALVE REPLACEMENT. A TIMEOUT WAS COMPLETED, VERIFYING CORRECT PATIENT, PROCEDURE SITE AND POSITIONING. GENERAL ANESTHESIA WAS INDUCED, AND CENTRAL VENOUS ACCESS WAS OBTAINED. AN ARTERIAL LINE AND FOLEY CATHETER WERE PLACED, A SWAN-GANZ CATHETER WAS POSITIONED, AND A TEE PROBE WAS PLACED. THE PATIENT WAS THEN POSITIONED, PREPARED AND DRAPED IN A STERILE MANNER. A COR-KNOT MINI COMBO DEVICE WAS USED TO SECURE THE SUTURES. PER RN REPORT: THE BLADES WERE DULLING BEFORE 6 CUTS WERE MADE AND THEY WERE NOT CUTTING THE SUTURES. THE DEVICE WAS REPLACED WITH ANOTHER SIMILAR ONE AND THE PROCEDURE WAS CONCLUDED WITH NO FURTHER INCIDENT. NO PATIENT HARM. MANUFACTURER RESPONSE FOR INSTRUMENT, LIGATURE PASSING AND KNOT TYING, COR-KNOT MINI® (PER SITE REPORTER). DEVICE AND INFO GIVEN TO MED FIELD REPRESENTATIVE