COMET II

Description of Event or Problem

REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 14MAR2026. IT WAS REPORTED THAT THE DEVICE COULD NOT BE EQUALIZED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ARTERY. A COMET II WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER PERFORMING EQUALIZATION SEVERAL TIMES, EQUALIZATION COULD NOT BE OBTAINED. EQUALIZATION COULD NOT BE PERFORMED CONTINUOUSLY WITH THE SECOND PIECE OF THE DEVICE, BUT EQUALIZATION WAS ABLE TO PERFORM WITH THE THIRD COMET DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE WIRE WAS FOUND DETACHED.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE SHROUD OF THE OCC CABLE WAS CONNECTED TO THE BENCH TOP TESTING EQUIPMENT, AND THE COEFFICIENT VALUES WERE CONFIRMED TO BE PROGRAMMED. INSPECTION OF THE DEVICE REVEALED THAT THE WIRE WAS FOUND DETACHED FROM THE TIP WELD AT 3.5CM FROM DISTAL TO PROXIMAL, ADDITIONALLY THE TIP WAS OBSERVED BENT. THE SHROUD OF THE OCC CABLE WAS CONNECTED TO THE FFR LINK FOR SIGNAL VERIFICATION. THE SIGNAL WAS NOT PRESENT, AS DESIGNED. DURING TESTING WITH THE FFR LINK, THE SIGNAL STRENGTH LED SHOWED A YELLOW OR ORANGE LIGHT AND THE ZEROED LED SHOWED A BLINKING RED LIGHT, INDICATING THAT THE WIRE WAS NOT WORKING APPROPRIATELY. THE LED LIGHTS FOR A PROPERLY WORKING WIRE ARE GREEN. THE SHROUD OF THE OCC CABLE WAS CONNECTED TO THE BENCH TOP TESTING EQUIPMENT. THE MODULATION WAS CHECKED BUT THERE WAS NO MODULATION (0%) FOR THIS DEVICE DUE TO WIRE DETACHMENT. THE SENSOR WAS FOUND DAMAGED. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: THIS INVESTIGATION HAS BEEN ASSIGNED AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE, FOLLOWING A REVIEW OF THE REPORTED EVENT DETAILS, AVAILABLE INFORMATION, AND PRODUCT RECORD REVIEW. DURING PRODUCT ANALYSIS IT WAS OBSERVED THE SENSOR DAMAGED, TIP BENT AND DETACHED, THESE ISSUES COULD BE RELATED TO AN EXCESSIVE FORCE APPLIED TO THE DEVICE DURING PROCEDURE, AS WELL AS OPERATIONAL FACTORS SUCH AS HANDLING OR TECHNIQUE, CAUSING THE REPORTED EVENT.