Manufacturer ref# (b)(4).Catalog#: igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: no product returned and very limited information provided.Based on the event description the exact reason for the advancement difficulties cannot be determined, but patient's tortuous anatomy may have caused the sheath to kink.Under normal conditions the sheath is strong enough to accomplish the procedure, but the sheath may kink if somehow exposed to excessive force during advancement.Reference is made to ifu: excessive force should not be used to place filter.Cook medical will continue to monitor for similar events.
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Description of event according to complainant: when starting the implantation of a vena cava filter, it became entrapped within the sheath just after the valve, making it impossible to move within the sheath.Was removed all the system and made new venipuncture.Patient outcome: a section of the device did not remain inside the patient's body.The patient did not require additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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