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 12 injections.No system notices triggered during functionally test of the catheter.A dissection showed a guide wire lumen kink 1.045 inches 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 cryoablation procedure, the balloon catheter shaft was twisted.The catheter was replaced with resolve, and the case was completed with cryo.The catheter 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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