It was reported that during a cryo ablation procedure, after the dilator of the sheath was removed, st elevation occurred.A coronary angiography was performed and showed that an air embolism had developed.Aspiration was performed with a competitor air suction catheter and intra aortic balloon pump.It was observed with an angiography and fluoroscopy.It was noted that during aspiration, cardiac arrest and ventricular fibrillation (vf) occurred three times and the patient was hypotensive.The patient recovered two hours after leaving the catheter lab.The case was aborted and it was noted that the patient was not under general anesthesia.No further patient complications have been reported as a result of this event.
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Product event summary: the sheath was returned and analyzed.Visual inspection of reported sheath 4fc12 lot number 72813 showed the device was intact with no apparent issues.Flushing and air aspiration testing did not show any air passing through the tube or expelled from the distal tip.However, functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve, and it was suspected that the valve disk is torn.In conclusion, the reported air ingress issue was confirmed through product testing.The clinical issues (cardiac arrest, air embolism, st elevation, hypotension, ventricular fibrillation, and aborted under general anesthesia) that were encountered during the case were not confirmed through product testing.The reported 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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