COR-KNOT MINI DEVICE KIT

Description of Event or Problem

COR KNOT MINI DEVICE DID NOT RELEASE THE FASTENER ONCE THE PURPLE LEVER WAS SQUEEZED. THE DISTAL TIP STUCK TO THE VALVE WITH BOTH DEVICES IN THE KIT ON THE 8TH AND 9TH ATTEMPT. THE DEVICE DID CUT THE SUTURE HOWEVER, DID NOT RELEASE THE FASTENER. AT THIS POINT THE SURGEON CUT THE TISSUE AROUND THE FASTENER AND APPLIED ANOTHER SUTURE THROUGH THE VALVE AND HAND TIED THE KNOT. MD THEN ATTEMPTED TO USE THE OTHER DEVICE IN THE KIT. THIS DID THE SAME AS PREVIOUS CUT THE SUTURE BUT DID NOT RELEASE THE FASTENER. STAFF STATED THE DEVICES WORKED SATISFACTORY UNTIL THE TWO MISS FIRES OCCURRED ON THE 8TH AND 9TH KNOT. AFTER THIS OCCURRED THE SURGEON HAND TIED THE REMAINING KNOTS. PRODUCT TAKEN BY THIRD PARTY VENDOR. PATIENT CODE: 4580. DEVICE CODE:1212, 2532. REF REPORT: MW5183946.