COMET II

Additional Manufacturer Narrative

DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF AN INCOMPLETE FFR COMET PRESSURE WIRE WITH THE OCC CABLE AND TORQUE DEVICE. THE SHROUD OF THE OCC CABLE WAS CONNECTED TO THE BENCH TOP TESTING EQUIPMENT. THE RFID TAG WAS DETERMINED, AND THE COEFFICIENT VALUES WERE CONFIRMED TO BE PROGRAMMED. VISUAL INSPECTION OF THE DEVICE REVEALED THAT THERE WERE NUMEROUS KINKS THROUGHOUT THE BODY FROM DISTAL TO PROXIMAL, ADDITIONALLY THE WIRE WAS FOUND DETACHED AT 39CM FROM DISTAL TO PROXIMAL.

Description of Event or Problem

REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15-NOV-2025. IT WAS REPORTED THAT THE PRESSURE GUIDEWIRE WAS KINKED. THE 28 MM X 3.0 MM, 80% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AN FG COMET II WAS ADVANCED FOR TREATMENT; HOWEVER, DURING THE PROCEDURE, THE PRESSURE GUIDEWIRE GOT KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHMENT.