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 respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was performed to treat a lesion in the heavily calcified, moderately tortuous, 99% stenosed left anterior descending coronary artery.A 2.5x12mm nc trek balloon dilatation catheter (bdc) failed to cross due to the anatomy and faced resistance with the anatomy during removal.A non-abbott device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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