(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.A pinhole leak was noted, confirming the reported failure to deploy.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 identified no similar incidents from this lot.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The 4.0 x 16 mm graftmaster referenced is filed under a separate medwatch report number.
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