(b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: the visual inspection confirms that the filter penetrated the sheath, and that the root cause most likely is a kink in the sheat.When and how this kink was made is unknown.It is noted that the procedure was completed successfully without any adverse event using a new device.Under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if excessive force is used to advance it through tortuous anatomy and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.There is no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will continue to monitor for similar events.
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Description of event according to initial reporter: the device was advanced from right internal jugular vein.While the advancement of the filter introducer through the sheath, the user noticed that the filter leg(s) perforated the sheath.Therefor, the whole system was removed from the patient's body and the same rpn of another lot product was used instead to complete the procedure.Patient outcome: there have been no adverse effects to the patient reported.
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