Exemption number e2019001.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.The other nc traveler is filed under a separate medwatch report.The traveler is currently not commercially available in the us; however, it is similar to a device sold in the us.
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It was reported that the procedure was to treat a lesion located in the proximal right coronary artery that was heavily calcified and moderately tortuous.An nc traveler was advanced, with resistance, to the lesion for pre-dilatation, but the balloon ruptured during the ninth inflation at 18 atmospheres.Intravascular ultrasound showed that the calcification was only somewhat reduced so another nc traveler was advanced with resistance and used, but it also ruptured during the sixth inflation at 14 atmospheres.Finally, rotablation was used to complete the procedure.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
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