WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-JP-JUG-TULIP |
Device Problems
Kinked (1339); Failure to Advance (2524)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/24/2013 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog #: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: the tulip filter, the filter introducer and the long dilator were returned.No indications of deformations on filter or introducer.However, on the introducer sheath a kink is observed approximately 36 cm from proximal end and a penetration of sheath is noted on the opposite site in the same area.Penetration may be due to physician continued to advance though strong resistance was met, as commented by the physician and the rep.Most likely tortous anatomy caused the sheath to kink resulting in resistance during advancement.Under normal conditions the sheath is strong enough to accomplish the procedure, but the filter legs may be prone to penetrate the sheath wall, if excessive force is used to advance the filter through the kinked sheath.No evidence to suggest that device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
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Event Description
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Description of event according to initial reporter: the device was used for dvt.Since there was a cv catheter inserted in the right jugular vein, access was gained from the left jugular vein.The vessel was tortuous due to the left jugular approach.Though the physician felt resistance during advancement of the filter introducer into the sheath, he continued to advance the introducer.When the filter legs was advanced at approximately 30 cm from the hub, anchors of the filter perforated the sheath.Since there was no other stock of gunther, another manufacturer's filter (optease/ cordis) was used and the filter was placed instead.Patient outcome: there have been no adverse effects such as complications or extension of hospital stay.
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