(b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Similar to device under 510(k): k090140.(b)(4).Summary of investigational findings: the description of event states that "there was tortuosity in patient's anatomy".Investigation of the introducer sheath demonstrates two kinks at 13 and 27 cm, the last kink represents the kink where the filter has perforated the sheath.Based on the information provided, it is not possible to conclude an exact root cause for the filter perforating the sheath.However it is considered likely that the filter was attempted advanced through a kinked sheath.In normal conditions the sheath is strong enough to accomplish the procedure, but it has previously been seen that the sheath may kink if somehow exposed to excessive force due to tortuous anatomy.If filter is advanced through a kinked sheath, the filter may exceed the sheath wall.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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