(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual and functional inspection was performed on the returned device.The reported inflation issue, leak, and failure to deploy were unable to be confirmed.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the sds was not securely attached to the inflation device resulting in the reported failure to deploy, inflation issue, and leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|