WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-1-UNI-CELECT-PT |
Device Problem
Component or Accessory Incompatibility (2897)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/02/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog: igtcfs-65-1-uni-celect-pt.(b)(4).Summary of investigational findings: investigation is based on event description and returned product.Femoral introducer and blue sheath returned, but the introducer could not be advanced through the sheath tip.Consequently, the compatibility between femoral cup and sheath tip may have caused the reported deployment difficulties, and the manipulation used may have caused the filter to tilt.Internal action is initiated to further investigate and prevent the issue.There is found 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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Event Description
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Description of event according to complainant: upon deploying, the legs were stuck in the sheath.After manipulation, the filter was able to be deployed.However, the filter is severely tilted within the patient.Patient outcome: the patient did not require and additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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