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 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, moderately tortuous, 90% stenosed lesion in the proximal left anterior descending (plad) artery.A 3.5x12mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion with resistance from the anatomy and inflated once to 7 atmospheres (atm) when the balloon ruptured.The bdc was removed without issue and a 3.25mm cutting 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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