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 90% stenosed, heavily calcified, mildly tortuous lesion in the proximal left anterior descending (lad) coronary artery.Resistance was noted with the lesion during advancement and the 4.00x8 mm nc trek balloon dilatation catheter (bdc) was inflated once to 12 atmospheres (atm) but ruptured.There was resistance with the anatomy during removal.A cutting balloon was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
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