(b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: only the filter was returned.Two primary legs were out of shape.All four secondary legs/blades were severely deformed, two of which were elongated/stretched parallel to their primary legs.Hardened blood was noted close to the clip bushing.Unable to determine exact reason for difficulties encountered, but due to the damages to the filter legs, it is suggested that after placement and withdrawal of sheath attempts were made to withdraw the expanded filter into the sheath.According to ifu "the pre-exposed filter can be advanced, but never pulled back into the sheath.Doing so will damage the shape of the filter." cook medical will continue to monitor for similar events.
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