(b)(4).Catalog # igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.Summary of investigational findings: investigation is based on event description, provided imaging, and returned product.Investigation of product showed both introducers working as intended.Device and filter were manufactured according to specifications, assuming filter was damaged during advancement through reported bent sheath.Sheath not returned, why unable to determine reason why "the filter got discharged in the sheath eventually teared the sheath" during insertion.Under normal conditions the sheath is strong enough to accomplish the procedure, but it may kink if advanced through tortuous anatomy and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.Cook medical will continue to monitor for similar events.
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