Catalog Number IGTCFS-65-1-JUG-TULIP |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/17/2017 |
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 initial reporter: deployment difficulty occurred during the procedure.Patient outcome: unknown.
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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 event description only.No product returned and without the actual complaint device it would be inappropriate to speculate at what may or may not have led to the difficulties in deploying/releasing the filter.However, it is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button.The ifu addresses the issue through the statement "while keeping slight back tension on the introducer, push the release button completely to ensure proper release of the filter" and the warning "excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated".No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.
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Search Alerts/Recalls
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