(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The other xact referenced is filed under a separate medwatch report number.Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.Analysis of the returned device revealed the blockage was material from the inner member of the catheter.It is likely that improper loading of the nav6 barewire most likely scratched the interior of the xact guidewire lumen and the shavings formed a blockage that prevented further advancement of the xact unit over the wire.The difficulty advancing over the guide wire was 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 of the reported lot did not reveal a lot specific product issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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