(b)(4).Catalog# igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: evaluation of this complaint is based solely on the description since no images or device have been available to assist the investigation.Therefore we are unable to determine exact reason for filter expanding difficulties.However, the filter may have been somehow obstructed from fully expanding, due to some biomechanical mechanisms e.G.A clot turning into fibrin formation or ivc anatomical conditions.Also the physician experienced difficulties when pressing the release button.Most likely this issue was caused due to possibility of clots/fibrin attachment while taking time before releasing the filter as.However the exact root cause for this issue is not to be determined based on the description and without investigation the device in question.No indications that this filter was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
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