Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).(b)(4).Summary of investigational findings: the femoral introducer, the tulip filter, and the dilator placed inside the sheath were returned.Assuming the "sheath diaphragm" was the check-flo valve of the sheath, the dilator was removed in order to investigate the valve, but it was found working as intended.The filter was found damaged with one "blade"/secondary leg bending upwards against the filter hook, thus suggesting attempts had been made to withdraw the femoral introducer with the filter through the valve after "sheath had slipped back so filter had to be removed." however, based on these findings the exact reason, why the filter "went in with a "pop"" in the first place, cannot be determined, but since the "sheath had slipped back so filter had to be removed", it is assumed that the filter was advanced and had to be repositioned, if inadvertently pre-deployed.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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