Device evaluated by mfr: the device was returned for analysis.Analysis of the tip, distal shaft, collar, and shaft included microscopic and visual inspection.Inspection revealed a partial separation of the shaft at the collar.Investigation of the rest of the device found no other damage or defect.
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Reportable based on device analysis completed on (b)(6) 2020.It was reported that the device could not cross the lesion.The target lesion was located in a tortuous distal end of 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 another of the same device.There were no complications reported and patient was stable.However, device analysis revealed partial separation of the shaft at the collar.
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