Device evaluated by mfr.: the returned complaint device consisted of an emerge balloon catheter.The balloon was loosely folded.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The hypotube was completely separated 72cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.There were numerous hypotube and shaft kinks along the device.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that could have contributed to the reported event.
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Reportable based on device analysis completed on 26-jul-2020.It was reported that shaft kink occurred.The 85% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, it was noted that the delivery shaft was kinked.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.
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