Reportable based on device analysis completed on (b)(6) 2024.It was reported that visualization issues occurred.The 80% stenosed, 15 x 3.50 mm target lesion was located in the moderately tortuous and moderately calcified right coronary artery.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion, but the device could not show the image.The procedure was completed with another of the same device.There were no patient complications reported and the patient condition following the procedure was stable.However, device analysis revealed the imaging window was observed detached near the lap joint section.
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