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Model Number 4FC12 |
Device Problems
Fluid/Blood Leak (1250); Gas/Air Leak (2946)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/01/2018 |
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 hemostatic valve of the sheath was leaking.Additionally, during aspiration, a lot of air was drawn, indicating air ingress.The sheath was replaced 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 64337, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was reproduced during the pressure test when the test dilator was introduced through the sheath.The hemostatic valve was leaking; 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 the leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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