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 complaint appears 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 heavily calcified, heavily tortuous, 90% stenosed lesion in the right coronary artery (rca).The 3.5x15mm trek rx balloon dilatation catheter (bdc) was advanced to the target lesion with resistance met and inflated two times to 8 atmospheres (atm), for 5 seconds for each inflation, when the balloon ruptured.The bdc was removed, without issue, and a non-abbott device was used to dilate the lesion before successfully completing the procedure with stenting.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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