(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The nc traveler rx is currently not commercially available in the us; however, it is similar to a device sold in the us.
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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.It was reported by the account that during inflation, the bdc was over-inflated to 19 atmospheres (atms) and the balloon ruptured.It should be noted that the coronary dilatation catheters (cdc), nc traveler, rx, global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc traveler device is 18 atm; therefore, rbp was exceeded.It could not be determined if inflating the balloon slightly over the rated burst pressure contributed to the rupture.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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