(b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Similar to device under 510(k): k090140.(b)(4).Summary of investigational findings: kink of the sheath most likely occurred due to left jugular approach and vein tortuosity as suggested by rep and physician.However, under normal conditions the sheath is strong enough to accomplish the procedure, but the introducer sheath may kink if excessive force is used to advance the introducer sheath through tortuous anatomy.Cook medical will continue to monitor for similar events.No evidence to suggest that this device was not manufactured according to specifications.
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Description of event according to initial reporter: on (b)(6) 2013, ivc filter placement was performed to treat deep vein thrombosis.The left jugular approach was selected as a cv catheter was placed in the right side.However, resistance was felt during advancement of the sheath, so it was removed and a kink was detected.Another one was used instead using the right jugular approach with the cv catheter in situ.The procedure was completed without problems.Patient outcome: no adverse effect to the patient.
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