(b)(4).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 should be noted the coronary dilatation catheters (cdc), (b)(4), instruction for use specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.The investigation determined the reported complaint appears to be related to operational context.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The nc traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.
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