Catalog Number IGTCFS-65-1-FEM-CELECT-PT |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/31/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog# igtcfs-65-1-fem-celect-pt.(b)(4).Investigation is still in progress.
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Event Description
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Description of event according to initial reporter: while putting the device through the femoral sheath, the device stopped advancing.The physician was uncomfortable with advancing further and pulled back, which deformed the filter.The device was removed from the patient and another of the same device was used to successfully complete the procedure.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 event description only.No product was returned to assist the investigation and without the actual complaint device, it would be inappropriate to speculate at what may or may not have caused the difficulties in advancing the filter through the sheath.However, filters advanced via femoral approach are attached to the femoral introducer by the primary filter legs only - the secondary filter legs are expanded and will be damaged if pulled back through the hub of the sheath.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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