Initial reporter facility name: (b)(6).Device evaluation by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 25.9cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
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Reportable based on device analysis completed on 27oct2020.It was reported that shaft kink occurred.The target lesion was located in the left main artery.A 3.00mm x 8mm nc emerge balloon catheter was advanced for use.However, during procedure, the delivery shaft was kinked at about 15 cm from the hub.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, device analysis revealed a shaft break.
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