(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Evaluation summary: visual inspection was performed on the returned device.The inaccurate delivery was not confirmed as the stent had already been deployed.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 revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported inaccurate delivery.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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