(b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Similar to device under 510(k): k090140.(b)(4).Summary of investigational findings: investigation of returned device confirms that sheath is kinked and perforated.Filter appears fine.Under normal conditions the sheath is strong enough to accomplish the procedure, but it is seen before that the sheath may kink if somehow exposed to excessive force because of tortuous anatomy.If the filter is advanced through a kinked sheath, the filter legs may be prone to exceed the sheath wall.In this case it is concluded that the damages observed to the device is a consequence of tortuous patient anatomy and following resistance during insertion.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 initial reporter: a patient experienced ivc filter placement with igtcfs-65-jp-jug-tulip.After right jugular vein was punctured, the sheath system was advanced to the target site successfully.However, since the curve of the neck vein was steep, the filter leg perforated the sheath when advancing the filter catheter ((b)(4)).The device was retrieved and replaced with another igtcfs-65-jp-jug-tulip (another lot#, (b)(4)).However, this second filter catheter got stuck in the sheath and could not be passed through the sheath.Puncture site was changed (to where:unknown) and another manufacture's temporary filter (new house protect / toray) was placed.Additional information received 27feb2013: when puncturing was conducted, the angle of the puncturing was almost 90° and thus the sheath got kinked.However, the physician did not notice the fact and advanced the filter, so the filter leg might have perforated the sheath.In addition, the physician did not change the angle/site of puncturing when using the second igtcfs-65-jp-jug-tulip.Therefore, it might not have passed through the sheath.Since the amount of the blood clots of the patient was very large, the physician selected optease whose capture rate of blood clots is high this time.Patient outcome: no information provided.
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