Model Number 4FC12 |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/20/2017 |
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, air was continuously introduced during aspiration.The sheath was replaced with resolve, and 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 30519 was returned and analyzed.Visual inspection of the sheath showed it was intact with no apparent issues.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath in straight condition.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve and the valve disk was suspected to be torn.Also, the dilator could not be snap locked into the sheath handle.The dilator luer was defective.In conclusion.The air ingress and dilator issue were confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve and damaged dilator luer.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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Event Description
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Additional information received indicated that air ingress was not alleged during the procedure.
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Search Alerts/Recalls
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