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 to treat a moderately calcified, moderately tortuous distal right coronary artery that is 100% stenosed.During advancement of the 1.2x6mm mini trek balloon dilatation catheter (bdc) resistance with anatomy was noted.The bdc was inflated 3 times to 13 atmospheres (atm) for 3 seconds each inflation.At the 4th inflation attempt at 13-14 atm, the balloon ruptured.Another balloon was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay.No additional information was provided.
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