(b)(4).Similar to device under 510(k) k090140.Summary of investigational findings: only the jugular introducer, introducer dilator with sheath, dilator and peel away sheath are returned for investigation.No filter is returned, nor the femoral introducer system.Unknown if the filter is advanced by jugular or femoral approach.The returned parts appear to be unused since no contamination and no deviation to the appearance of a new/unused product.The description "the filter was lean after deployed.The two main leg were not complete deploy" is taken in as filter not expanding.Based on the limited information we are unable to determine exact reason for filter expanding difficulties.However, the filter may have been somehow obstructed from fully expanding, either due to a clot turning into fibrin formation or due to other biochemical mechanism during the procedure.Cook medical will continue to monitor for similar events.
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