Product event summary: the sheath, 4fc12 with lot 30510, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.The valve disk is suspected to be torn.In conclusion, the reported aspiration issue has been confirmed through testing.The reported sheath, 4fc12 with lot 30510, 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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It was reported that during a cryoablation procedure, aspiration was attempted but unable to be performed.The balloon catheter was reinserted without resolve.The sheath was then replaced with resolve, and the case was completed with cryo.No patient complications have been reported as a result of this event.The sheath subsequently tested out of specification per the manufacturer's investigation.
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