Catalog Number IGTCFS-65-1-JUG-TULIP |
Device Problems
Leak/Splash (1354); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/18/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) investigation is still in progress.
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Event Description
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Description of event according to complainant: upon initial deployment of the tulip filter (jugular), the primary struts did not appear to expand all the way and gain wall apposition.The filter was retrieved and upon the post removal cavagram, there appeared to be some possible extravasation.An angioplasty balloon then was placed in the ivc and inflated to stop the possible extravasation.A second tulip filter (jugular) was then successfully deployed.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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(b)(4).Summary of investigation findings: based on a review of the provided imaging in all likelihood the filter was inadvertently deployed with the feet engaging the ostium of the large vertebral vein inhibiting the filter from deploying appropriately in ivc.Following filter retrieval likely lacerated the vertebral vein ostium.Investigation found no evidence to suggest the product was not manufactured according to specifications and there is no reason to believe the problem was inherent in the filter.Cook medical will continue to monitor for similar events.
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Event Description
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Description of event according to complainant: upon initial deployment of the tulip filter (jugular), the primary struts did not appear to expand all the way and gain wall apposition.The filter was retrieved and upon the post removal cavagram, there appeared to be some possible extravasation.An angioplasty balloon then was placed in the ivc and inflated to stop the possible extravasation.A second tulip filter (jugular) was then successfully deployed.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Search Alerts/Recalls
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