Image analysis summary: the hawkone device was not received for evaluation.No ancillary devices from the procedure were received for evaluation.Three photographic images were received with the initial reported event.The first image is of the hawkone directional atherectomy system distal assembly.Approximately at half the distance between cutter window and the distal tip a bulge in the tecothane between two struts is present.The bulge of material appears to run parallel to the struts.Due to the quality and clarity of the image it is not possible to determine if a breach in the tecothane is present, presence of mec holes along the length of the distal assembly, or if a strut is damaged.Due to the angle of the photograph the guidewire lumen is not visible: it is not possible to determine if evidence of guidewire prolapse is present.The cutter head is not present in the cutter window.The location of the cutter head within its packing stroke within the distal assembly cannot be determined in the photograph.The second image is of a cine image and appears to be a before treatment cine.The third image is a cine image and appears to be an after-treatment cine.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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