(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.A conclusive cause for the inflation issue and balloon twisting could not be determined.Without having the armada 18 to examine, a conclusive cause for the inflation issue could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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