Product event summary: the device and data files were returned and analyzed.Data files showed that 3 applications were performed with the catheter.The applications were not sustained (could have been stopped by physician) on the date of the event.Also, the 14 applications were performed with another balloon catheter without any issue 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 3 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 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 prior to a cryo ablation procedure, the shaft tip of the balloon catheter was bent during aspiration.Inflation was again attempted without resolve.The balloon catheter was then replaced and the case was completed with cryo.No patient complications have been reported as a result of this event.The balloon catheter was returned to the manufacturer, analyzed, and tested out of specification.
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