(b)(4).Summary of investigational findings: two sheath were received for investigation.The two sheaths were used for one patient.Sheath no.1 has a severe kink and penetration appears approx 25 cm from distal end.Sheath no.2 has a severe penetration appears approx 25 cm from distal end.Under normal conditions the sheath is strong enough to accomplish the procedure, but it has been 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/severely curved sheath, the filter legs may be prone to exceed the sheath wall.There is a possibility of injury to the blood vessel or damage to this device.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: the device was inserted from the left jugular vein.After checking bloodstream, the filter introducer was advanced into the sheath carefully.However, it made the sheath kink.Then, another same device was used instead, but the same event occurred since vessel (vein) damage was confirmed, the procedure was finished.Additional information received (b)(6) 2013: the reason why the approaching point was from left was that hematoma occurred in the access route of the right jugular vein.On (b)(6) 2013, dissection was confirmed but the physician decided to take a wait-and-see approach.Patient outcome: there has been no patient outcome reported.
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