Device evaluated by manufacturer: the device was returned for analysis.Analysis of the tip, distal shaft, collar, hypotube and strain relief included microscopic and visual inspection.Inspection revealed a partial separation in the shaft and numerous kinks in the hypotube.Inspection of the rest of the device found no other damage or defect with the device.
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Reportable based on device analysis completed on 31aug2020.It was reported that the device could not cross lesion.The 24mmx3.5mm, 90% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A guidezilla guide extension catheter was selected for use.During procedure, it was noted that the device could not cross the lesion.The procedure was completed with a different device.There were no complications reported and patient was stable.However, device analysis revealed a partial separation in the shaft.
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