COMET II

Additional Manufacturer Narrative

DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. INSPECTION OF THE DEVICE REVEALED THAT THE TIP WAS FOUND BENT AND STRETCHED. 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, AS DESIGNED. THE GREEN LED LIGHTS INDICATED THE WIRE WAS 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. THE SHROUD OF THE OCC CABLE WAS CONNECTED TO THE BENCH TOP TESTING EQUIPMENT. THE MODULATION WAS CHECKED AND WAS 13.6 PERCENT. 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.

Description of Event or Problem

IT WAS REPORTED THAT PRESSURE GUIDEWIRE FRACTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED JUNCTION OF THE FIRST DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY. THE FG COMET II PRESSURE GUIDEWIRE WAS SELECTED FOR USE AND THE TIP WAS RESHAPED MULTIPLE TIMES IN ORDER TO ADVANCE INTO THE LESION. DURING INSERTION, A KINK OCCURRED APPROXIMATELY 2 MM TO 3 MM FROM THE TIP AND WHEN THE WIRE ENCOUNTERED CALCIFICATION, THE TIP FRACTURED WITHOUT PASSING THROUGH THE LESION. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT ADVERSE EVENT WAS REPORTED.

Description of Event or Problem

IT WAS REPORTED THAT PRESSURE GUIDEWIRE FRACTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED JUNCTION OF THE FIRST DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY. THE FG COMET II PRESSURE GUIDEWIRE WAS SELECTED FOR USE AND THE TIP WAS RESHAPED MULTIPLE TIMES IN ORDER TO ADVANCE INTO THE LESION. DURING INSERTION, A KINK OCCURRED APPROXIMATELY 2 MM TO 3 MM FROM THE TIP AND WHEN THE WIRE ENCOUNTERED CALCIFICATION, THE TIP FRACTURED WITHOUT PASSING THROUGH THE LESION. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT ADVERSE EVENT WAS REPORTED.