Catalog Number IGTCFS-65-1-JUG-TULIP |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog #: igtcfs-65-1-jug-celect-pt investigation is still in progress.
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Event Description
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Description of event according to initial reporter: the filter wouldn't deploy from the hook.After some manipulation the filter came off the hook and placement was as intended.Patient outcome: the patient did not require any additional procedures due to this occurrence.No adverse effects to the patient due to this occurrence.
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Manufacturer Narrative
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Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Catalog#: igtcfs-65-1-jug-tulip.Investigation is still in progress.
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Manufacturer Narrative
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Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: the jugulare introducer and the long dilator are returned.The grasping hook is tested using a sample filter and works as intended.The root cause for the reported difficulties cannot be determined.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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Search Alerts/Recalls
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