OPTOWIRE III

Additional Manufacturer Narrative

THE OPTOWIRE WAS RECEIVED FOR INVESTIGATION ON JUNE 5TH 2026. THE OPTOWIRE WAS RECEIVED CONNECTED TO ITS FOIC HANDLE. CONNECTION TO OUR OPTOMONITOR SYSTEM WAS SUCCESSFUL WITH GOOD SIGNAL. VISUAL INSPECTION ON THE WIRE WAS PERFORMED. VERY SLIGHT CURVATURES WERE OBSERVED AT 10 AND 23 CM FROM THE PROXIMAL END. A SMALL KINK WAS ALSO OBSERVED AT THE PROXIMAL JOINT BETWEEN THE SHAFT AND THE INTERIM SECTION. A FRACTURE OF THE TIP WAS NOTICED. BASED ON THE EXTENT AND ON THE NATURE OF THE FRACTURES, IT IS ESTIMATED THAT RESISTANCE WAS ENCOUNTERED IN THE HEAVILY CALCIFIED LESION (CALCIUM SCORE OF 3000 IS AT THE EXTREME END OF THE CORONARY CALCIUM SCORE SPECTRUM). THE LIKELY ORDER OF OCCURRENCE OF THE FRACTURES IS THAT THE CORE WIRE BROKE UNDER TENSION. THE PROXIMAL COIL SOLDER THEN TORE AS THE COIL SEPARATED FROM THE CORE WIRE (A, B, C). THE PROXIMAL SOLDER SHOWS THAT SOME MATERIAL CAME OFF (D), INDICATING THAT THIS SOLDER IS COMPLIANT. THE FRACTURES WERE MOST LIKELY CAUSED BY EXCESSIVE TENSION APPLIED BY THE CLINICIAN. REVIEW OF DEVICE HISTORY RECORDS CONFIRMED THAT THE OPTOWIRE III LOT NUMBER OW-4017D HAD BEEN RELEASED PER SPECIFICATIONS. TWO (2) OTHER COMPLAINTS WERE RECEIVED ON THIS LOT, BOTH UNRELATED TO THE EVENT DESCRIBED IN THIS COMPLAINT. BASED ON THE EVENT DESCRIPTION AND ON THE INVESTIGATION, THE WIRE TIP FRACTURES ARE LIKELY RELATED TO THE USAGE OF THE DEVICE BEYOND THE RECOMMENDATIONS PROVIDED IN THE INSTRUCTIONS FOR USE (IFU)(LBL-2020-06-V4 OW3 IFU F1032):

Description of Event or Problem

THE LAD AND RCA WERE CALCIFIED, THE CALCIUM SCORE WAS 3000. CARDIOLOGIST DECIDED TO USE THE OPSENS WIRE TO LOOK AT THE DPR/FFR OF LEFT CIRCUMFLEX ARTERY (LCX). HOWEVER, BEFORE DPR/FFR WAS CONDUCTED, CARDIOLOGIST REALISED THAT THE WIRE HAS FRACTURED AND THE DISTAL PART LEFT IN THE LCX. HE WAS UNABLE TO RETRIEVE WITH A SNARE AND THE PATIENT WAS TRANSFERRED TO PENINSULA PRIVATE FOR EMERGENCY CABG. PATIENT WAS STABLE WHILE TRANSFERRING OUT.