(b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) (b)(4).(b)(4).Summary of investigational findings: image review confirmed that difficulties appear during release of the filter.However, unable to determine exact reason for difficulties encountered during attempted filter deployment, but it is seen before that to much back tension while release button is pushed could cause deployment difficulties/failure.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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The device was approached from the jugular vein.The physician screwed the red hub and pushed the metal knob to release the filter after expansion of the filter though, the filter would not be detached from the filter introducer.Since the filter looked detached from the grasping hook on the screen finally after several attempts of filter release, the physician withdrew the introducer from the patient.However, the filter moved as if it was still connected to the introducer.After several attempts of withdrawing the introducer, the introducer could be removed from the patient with a sound like thread breakage.Patient outcome: there have been no adverse effects to the patient reported.
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