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 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, moderately tortuous right coronary artery (rca) that is 90% stenosed.The 3.50x12mm nc trek balloon dilatation catheter (bdc) met resistance during advancement with anatomy.The bdc was inflated once to 13 atmospheres; however, the bdc ruptured at an unknown pressure.Additionally, resistance with anatomy was noted during removal of the bdc.Another non-abbott device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay.No additional information was provided.
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