(b)(4).Catalog # igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.Summary of investigational findings: the investigation is based on the event description and provided imaging.Product was not returned.According to images, the filter hook had penetrated the sheath as reported, but as no sign of extravasation it may not have perforated the femoral vein.Furthermore on images four secondary legs were bent and pushed towards the filter hook, as if attempts were made to pull the filter back into the sheath after "the filter perforated the introducer".Under normal conditions the sheath is strong enough to accomplish the procedure, but it is seen before that the sheath may kink, if exposed to extensive force, and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.From the ifu: "excessive force should not be used to place the filter" and "the pre-exposed filter can be advanced, but never pulled back into the sheath.Doing so will damage the shape of the filter." 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 patient has very tortuous right femoral vein.The radiologist had difficulties to access to inferior vena cava.During the progression of the introducer in the femoral and iliac vein, the introducer kinked (due to the tortuous anatomy).They pulled and pushed on the introducer to make it straight again.Just after they introduced the filter it made a difficult progression into the introducer, and the filter perforated the introducer and the femoral vein.Patient outcome: the filter stayed in right femoral vein.The patient went to the operating room to have the filter retrieved by a vascular surgeon.
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