Product event summary: the device was returned and analyzed.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 balloon tip.Pressure testing did not show leaks.In conclusion, the reported kink issue was confirmed through testing.The balloon 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 during a cryo ablation procedure, the shaft of the balloon catheter was bent.The push button of catheter was pressed, 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 mapping catheter was returned to the manufacturer, analyzed, and tested out of specification.
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