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 identified no other similar incidents and/or complaints from this lot.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 performed to treat a lesion in the heavily calcified, mildly tortuous, 90% stenosed proximal left anterior descending coronary artery.A 3.75x12mm nc trek balloon dilatation catheter (bdc) experienced resistance with the anatomy during advancement.The balloon ruptured during the first inflation at 12 atmospheres, and the bdc experienced resistance with the anatomy during removal.A 3.5x12mm nc trek balloon 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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