Model Number G34309 |
Device Problems
Difficult or Delayed Positioning (1157); Activation Failure (3270)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog# igtcfs-65-1-jug-celect-pt.Name and address for importer site: (b)(4).Investigation is still in progress.
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Event Description
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Description of event according to initial reporter: "celect pt filter did not deploy properly.3 of the 4 primary struts did not fully open as they were tangled together.Filter fully deployed with struts entangled, celect pt filter was retrieved using a snare and second celect pt filter was deployed successfully." patient outcome: the patient did not require any 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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Manufacturer Narrative
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Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on description of event and returned product.The filter is returned.No anomalies noted.The diagonals measure 38 and 36.5 mm, respectively, which is with specifications.The root cause for the reported deployment issues cannot be determined.No evidence to suggest that this product 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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