Product event summary: the device and data files were returned and analyzed.Data files showed that 12 applications were performed with the catheter on the date of the event.Also, 4 more applications were performed with another balloon catheter without any issues on the date of the event.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 12 injections.A dissection showed a guide wire lumen kink 1.40 inches from the tip inside the balloons.Pressure testing did not show leaks.In conclusion, the reported kink issue was confirmed through testing.The catheter failed the return inspection test 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, the balloon catheter sleeve was damaged, and it was not working as expected.The catheter was replaced and the case was completed with cryo.No patient complications have been reported as a result of this event.The device was returned to the manufacturer, analyzed, and tested out of specification.
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