COMET II

Additional Manufacturer Narrative

DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SHROUD OF THE OCC CABLE WAS CONNECTED TO TESTING EQUIPMENT WHICH CONFIRMED THE COEFFICIENT VALES WERE PROGRAMMED. VISUAL INSPECTION SHOWED THAT THE DEVICE BODY WAS KINKED AT 173CM FROM DISTAL TO PROXIMAL, AND THE TIP WAS FOUND BENT AND STRETCHED. MICROSCOPIC ANALYSIS FOUND THE CORE WIRE DETACHED FROM THE SPRING TIP. DURING A DEVICE-TO-DEVICE INTERACTION TEST, THE SHROUD OF THE OCC CABLE WAS CONNECTED TO THE FFR LINK TO VERIFY THE SIGNAL STRENGTH. THERE WERE NO ISSUES IN CONNECTING TO THE FFR LINK. THE SIGNAL WAS PRESENT, AND THE SIGNAL STRENGTH AND THE ZEROED LED LIGHTS SHOWED GREEN WHICH INDICATES THAT THE WIRE IS WORKING PROPERLY. THE DEVICE WAS THEN CONNECTED TO THE POLARIS (ILAB) TEST EQUIPMENT VIA BLUETOOTH SIGNAL. THE WIRE COMMUNICATED TO THE POLARIS SYSTEM AND ZEROED, AS DESIGNED. WITH THE WIRE INSERTED INTO THE TEST PRESSURE CHAMBER, THE WIRE TRANSFERRED A PRESSURE WAVEFORM TO THE POLARIS WHICH INDICATES A FUNCTIONING WIRE. DURING FUNCTIONAL TEST, THE SHROUD OF THE OCC CABLE WAS CONNECTED TO THE BENCH TOP TESTING EQUIPMENT. THE MODULATION WAS CHECKED AND WAS 15.1%. THE WIRE WAS INSERTED INTO THE PRESSURE CHAMBER. THE PRESSURE WAS INCREASED TO VERIFY THE SENSOR WAS INDEED REACTING TO THE PRESSURE INCREASES AND DECREASES. THE PRESSURE SENSOR FUNCTIONED AS DESIGNED. ADDITIONALLY, THE WIRE COULD BE LOCKED AND UNLOCKED FROM THE HANDLE.

Description of Event or Problem

REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 26SEP2025. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS THE LESION AND WOULD NOT DISCONNECT FROM THE HANDLE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A COMET II PRESSURE GUIDEWIRE WAS USED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE DEVICE COULD NOT CROSS THE LESION, AND THE WIRE WOULD NOT DISCONNECT FROM THE HANDLE EVEN AFTER UNLOCKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE CORE WIRE WAS DETACHED FROM THE SPRING TIP.