Product event summary: the device and data files were returned and analyzed.Data files showed that 2 applications were performed with the balloon catheter on the date of the event with no issues.Also, data files showed that 8 applications were performed with another balloon catheter without any issues.Visual inspection of the catheter showed that the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for 1 injection.The catheter failed the performance test due to a kink on the guide wire lumen under the balloon segment.A dissection showed a guide wire lumen kink 1.38 inches from the tip, inside the balloons.In conclusion, the reported kink issue was confirmed through testing.The catheter failed the returned product inspection due to 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 shaft of the balloon catheter was bent while inflation was performed outside of the body.The push button was maneuvered without resolve.The balloon catheter was replaced.The case was completed with cryo.The device was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.
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