Reportable based on device analysis completed on (b)(6) 2018.It was reported that lost image occurred.An 80% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal left anterior descending (lad).During percutaneous coronary intervention, an opticross imaging catheter was selected for use, however, no image occurred.There were no patient complications that were reported.However, returned device analysis revealed mechanical cut at the sheath.Device evaluated by mfr: the product was returned for analysis. only a segment of the opticross was received.The device was cut off at the proximal section and the sheath was detached.The distal sheath section was not returned.The sheath has evidence of a mechanical cut in the sheath.The image test could not be performed due to the device conditions.
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