The return device analysis confirmed the reported leak at luer of the hemostasis valve.Furthermore, the luer was noticed to have a crack.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the investigation, the reported leak appears to be due to observed crack on hemostasis valve luer.The investigation determined the observed crack on hemostasis valve luer may be related to a product quality issue.The issue is being addressed per internal operation procedure.Abbott vascular will continue to trend the performance of these devices.
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