Product event summary:the device and data files were returned and analyzed.Data files showed 16 injections were performed with the catheter.It was confirmed that a system notice indicating that the safety system detected a compromised outer vacuum (# (b)(4)) during injections.Visual inspection of the catheter showed that the device was intact with no apparent issues.Smart chip verification indicated that the catheter was used for 16 injections.No system notice triggered during functional testing.A dissection showed a guide wire lumen kink 1.35 inches from the tip inside the balloons.Pressure testing did not show leaks.In conclusion, the catheter failed the return inspection due to a guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.
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It was reported that during a cryo ablation procedure, a system notice was received indicating that the safety system detected a compromised outer vacuum.The balloon catheter was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.The catheter was returned to the manufacturer, analyzed, and tested out of specification.
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