Event summary: the patient data files showed at least eight injections were performed with catheter 2af283 / 37334-69 on the date of the event with no system notice.Upon visual inspection of the sheath 4fc12 / 58281-066, results showed the device was intact with no apparent issues.Air aspiration was reproduced when a test arctic front catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking; valve was torn.The sheath failed the test due to leaking homeostatic valve.In conclusion, the reported issue (air ingress) has been 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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