Event summary: the patient data files showed at least nineteen applications were performed with catheter 2af283/05456-15 without any issue on the date of the event.Upon visual inspection of the sheath 4fc12 / 99926-80, results showed the device was intact with no apparent issues.Air aspiration was reproduced when a test catheter was introduced through the sheath in the straight condition.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.It was suspected that the valve disk was torn.In conclusion, the reported issue air ingress during aspiration has been confirmed through testing but not confirmed through the data analysis.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.
|