It was reported that a shaft break occurred.The target lesion was located in the left anterior descending artery (lad).A 1.50 mm x 15 mm emerge was used to dilate the lesion.The emerge balloon was deflated and removed.During washing of the device, the balloon shaft broke.No patient complications were reported in relation to this event.Device evaluated by mfr: returned product consisted of an emerge balloon catheter in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 64.9cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.
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