Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: a jugular introducer and a celect-pt filter were returned.Investigation found the filter manufactured according to specifications and revealed no damages.Based on these findings and since no imaging was provided, the exact reason, why the legs of the filter would not deploy cannot be determined.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended.Cook medical will continue to monitor for similar events.
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