COR-KNOT MINI COMBO KIT

Description of Event or Problem

DURING AN AORTIC VALVE REPLACEMENT PROCEDURE, THE COR-KNOT DEVICE USED TO SECURE THE VALVE SUTURES MISFIRED OUTSIDE THE SURGICAL CAVITY WHILE A SUTURE WAS BEING THREADED. THE SUTURE WAS SUBSEQUENTLY CUT, AND THE SURGICAL TEAM HEARD ONE QUICK LOAD DETACH AND FALL FROM THE DEVICE. THE SMALL TACK-LIKE COMPONENT COULD NOT BE IMMEDIATELY LOCATED. THE PROCEDURE WAS PAUSED, AND ALL TEAM MEMBERS PARTICIPATED IN A SYSTEMATIC SEARCH OF THE PATIENT, SURGICAL CAVITY, DRAPES, INSTRUMENT FIELD, AND OPERATING ROOM FLOOR FOR THE MISSING QUICK LOAD. THE ITEM WAS NOT FOUND. AN INTRAOPERATIVE X-RAY WAS OBTAINED TO ASSIST WITH LOCATING THE MISSING COMPONENT. THE SURGEON REVIEWED THE X-RAY AND WAS UNABLE TO IDENTIFY THE MISSING QUICK LOAD. ADDITIONALLY, THE SURGEON REPORTED BEING UNABLE TO VISUALIZE THE OTHER 13 INTENTIONALLY DEPLOYED QUICK LOADS ON THE IMAGING. AFTER ASSESSMENT OF THE SITUATION AND REVIEW OF THE AVAILABLE IMAGING, THE SURGEON DETERMINED THAT IT WAS APPROPRIATE TO PROCEED WITH COMPLETION OF THE PROCEDURE AND SURGICAL CLOSURE. THE RADIOLOGY READING WAS NEGATIVE FOR RETAINED FOREIGN OBJECT - THERE WAS NO APPARENT HARM TO THE PATIENT.