Device evaluated by manufacturer: the device was returned for analysis.Analysis of the tip, distal shaft, collar, and hypotube included microscopic and visual inspection.Inspection revealed tip damage (flattened), shaft damage (flattened) for a length of 4.8cm that started at the tip, and collar damage.Inspection of the rest of the device found no other damage or defect.
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Reportable based on device analysis completed on 13aug2020.It was reported that the device could not cross lesion.The target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 7f guidezilla ii guide extension catheter was selected for use.During procedure, it was noted that the device could not cross due to calcification.The procedure was completed with another of the same device.There were no complications reported and patient was good post procedure.However, device analysis revealed collar damage.
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