Catalog Number IGTCFS-65-1-JUG-CELECT-PT |
Device Problems
Kinked (1339); Material Perforation (2205)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog #: igtcfs-65-1-jug-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: they were placing the device in the patient with a jugular approach and the shaft of the delivery system kinked.They removed and placed a new filter successfully.Patient outcome: the patient did not experience any adverse effects due to this event.
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Manufacturer Narrative
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Exemption number e2016032.(b)(4).Summary of investigational findings: the introducer sheath containing the 7.0 fr.Dilator was returned.The sheath has a penetration 26 cm to 27 cm from the hub.There is a minor kink approx.24 cm from the hub.Based on limited information provided the exact reason for the penetration cannot be determined and under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if excessive force is used to advance it through tortuous anatomy and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.According to the ifu: excessive force should not be used to place the filter.There is no evidence to suggest that the 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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