It was reported that during a cryo ablation procedure, the guide wire lumen appeared to be off-centered.The balloon catheter was replaced but the issues persisted.Then, the balloon catheter was replaced again with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.
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Product event summary: the data files and balloon catheter 2af284 with lot number 62780, were returned and analyzed.The data files showed at least fourteen applications were performed with this catheter and there were no issues or system notices.Visual inspection of the catheter showed the device was intact with no apparent issues.Dissection showed a guide wire lumen kink at 0.95 inches from the tip inside the balloons.Pressure tests 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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