(b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: an investigation revealed two kinks on the sheath, but no sign of penetration.However, one of the secondary filter legs was pushed towards the filter hook, thus indicating a penetration of the primary leg as reported.Under normal conditions the sheath is strong enough to accomplish the procedure.However, the sheath may kink, if exposed to extensive force because of tortuous anatomy and the filter may be prone to exceed the sheath wall if the introducer system is advanced through a kinked sheath.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
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