Product event summary: the device and data files were returned and analyzed.Data files showed that 20 injections were performed with the balloon catheter without any issues.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 20 injections.A dissection showed a guide wire lumen kink 1.0 inch from the tip inside the balloons.Pressure testing did not show any leaks.In conclusion, the reported kink issue was confirmed through testing.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, the balloon catheter was stuck in one direction and the steering mechanism was defective.The case was able to be 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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