The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a heavily calcified, heavily tortuous, 90% stenosed lesion in the distal right coronary artery (drca).A 2.0x12mm mini trek balloon dilatation catheter (bdc) was advanced but could not cross the anatomy to reach the target lesion.The bdc was removed with resistance from the anatomy.There was no adverse patient effect and no clinically significant delay in the procedure.Another same size mini trek bdc was used to successfully complete the procedure.No additional information was provided.
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