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 difficulties appear to be related to circumstances of the procedure.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 moderately calcified, mildly tortuous, 90% stenosed, de novo lesion in the mid right coronary artery (mrca).A 3x12mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion with resistance from the anatomy and inflated one time to 12 atmospheres (atm) and held for 10 seconds when the balloon ruptured.The bdc was removed without issue and a non-abbott device was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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