Catalog Number IGTCFS-65-1-JUG-TULIP |
Device Problems
Positioning Failure (1158); Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog #: igtcfs-65-1-jug-tulip.Investigation is still in progress.
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Event Description
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Description of event according to the initial reporter: the catheter with the filter in it would not advance further down into the sheath.The doctor pulled the delivery catheter out.He hand injected contrast and the contrast came out the side of the sheath.The doctor put a wire down and removed the sheath.He completed the procedure successfully over that wire with a new filter kit.Patient outcome: there was no harm to the patient.
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Catalog#: igtcfs-65-1-jug-tulip.(b)(4).Summary of investigational findings: the blue sheath and the introducer with filter inside the protection sheath were returned.The red locking mechanism is not pressed, ie the system is still locked.The blue sheath is severely penetrated approx.18.5-19.5cm from the fitting and two kinks are noted close to the penetration.The protection sheath is kinked in the area, where the filter is loaded to the introducer.The tip of the protection sheath is slightly squeezed.Due to of the kinks, the root cause for the reported event is determined to be a difficult approach in the patient (eg.Tortuous anatomy) and user technique.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 legs may be prone to exceed the sheath wall, if advanced through a kinked sheath.The ifu states that excessive force should not be used to place the filter.It is noted that the event did not harm the patient and that the procedure was successfully completed by use of a new filter kit.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.
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Event Description
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Description of event according to the initial reporter: the catheter with the filter in it would not advance further down into the sheath.The doctor pulled the delivery catheter out.He hand injected contrast and the contrast came out the side of the sheath.The doctor put a wire down and removed the sheath.He completed the procedure successfully over that wire with a new filter kit.Patient outcome: there was no harm to the patient.
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Search Alerts/Recalls
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