COOK, INC. GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-FEM |
Device Problems
Migration or Expulsion of Device (1395); Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problem
Foreign body, removal of (2365)
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Event Date 04/27/2014 |
Event Type
Injury
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Event Description
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A pt underwent filter placement on (b)(6) 2104.The legs of gunther tulip femoral vena cava filter failed to expand after being deployed in the pt, leading to the filter migrating to the right atrium of the heart.A retrieval kit was used to successfully snare the filter for removal.Another manufacturer's device was used to complete the procedure and no harm was done to the pt.A section of the device did not remain inside the pt's body.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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(b)(4).Event is still under investigation.
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Search Alerts/Recalls
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