Model Number 4FC12 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/10/2019 |
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 balloon catheter was inserted into the sheath and air was introduced.The sheath was replaced with resolve.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 0009925327 was returned and analyzed.Visual inspection showed the device was intact with no apparent issue.Air aspiration was reproduced during the aspiration test when the test catheter was introduced through the sheath.The hemostatic valve was leaking.Further dissection didn't show any leak along the shaft in the handle.In conclusion, the reported air ingress issue 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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Search Alerts/Recalls
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