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 to treat a moderately calcified, mildly tortuous, 90% stenosed lesion in the distal left anterior descending (dlad) artery.A 3x15mm 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) when the balloon ruptured.The bdc was removed with resistance from the anatomy and a new bdc 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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