Product event summary: the device and data files were returned and analyzed.Data files showed that 1 application was performed with balloon catheter 71612 and catheter 2af284 / 71612 without any issues on the date of event.Also, 11 applications were performed with another balloon catheter 2af284 / 06353 without any issues.Visual inspection of the balloon catheter showed that the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for 1 injections.The catheter passed the performance test, but inflation showed a kink on the guide wire lumen under the balloon segment.A dissection showed a guide wire lumen kink.99 inches from the tip, inside the balloons.In conclusion, the reported kink issue was confirmed through testing.The catheter failed the return product 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 shaft was bent.The balloon catheter was replaced and the second balloon catheter also displayed a slight bend.That catheter was then replaced with resolve.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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