(b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: the complete set is returned - except for the filter.The jugular introducer is unused.The femoral introducer is slightly bent.When pressing the release button, hardened blood was pushed out at the distal end.However, the piston moved freely and no damages were noted anywhere on introducer.It is assumed, that the secondary filter legs were not expanded as well, since filter was removed and "changed another product to finish the procedure." however, since the filter was not returned and no images were provided, it is not possible to determine the root cause for why the "filter was not completely released during use as the primary filter leg was not completely open".No evidence to suggest product was not manufactured to specifications.Cook medical will continue to monitor for similar events.
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