(b)(4).Catalog# igtcfs-65-1-uni-celect-pt (b)(4).Summary of investigational findings: no product or images have been received for investigation, such that the evaluation is based on the description solely.Based on the information provided, 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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Description of event according to complainant: the filter would not deploy.After several attempts from the jugular approach, the filter would not unhook from the system.The physician re sheathed the filter a few times and then was finally able to detach it from the deployment system.Everything ended up being ok.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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