Model Number 4FC12 |
Device Problems
Air Leak (1008); Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryo ablation procedure, the valve could not stop introducing air into the sheath.More than 20cc of air was extracted.The sheath was pulled out and replaced.The case was completed with cryo.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the sheath, 4fc12 with lot number 70897 was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issue.Flushing/ air aspiration testing did not show any air passing through the tube or expelled from the distal tip.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.The valve disk was suspected to be torn.In conclusion, the reported air ingress was confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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