(b)(4).Catalog#: igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: no product returned and without actual complaint device, the exact reason for the deployment difficulties cannot be determined, however it is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button.From the ifu: - while keeping slight back tension on the introducer push the release button completely to ensure proper release of the filter.Repositioning of the filter is no longer possible.The filter is now released.- excessive tension during deployment may prevent the filter from releasing when release mechanism is activated.There is found 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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