Product event summary: the data files and balloon catheter, 2af284 with lot number, 96466 were returned and analyzed.The data files showed that at least 3 applications were performed with the returned balloon catheter on the date of the event without any issues or system notices.Also, 13 applications were performed with a different balloon catheter without any issues or system notices on the date of the event.Visual inspection of the returned balloon catheter showed the catheter was intact with no apparent issue.Dissection showed that guide wire lumen kinked on 1.3055 inches from the tip of the catheter.In conclusion, the catheter failed the performance test and returned product inspection due to the kink on the guide wire lumen.If information is provided in the future, a supplemental report will be issued.
|
It was reported that during a cryo ablation procedure, the balloon catheter would not extend, and it was indicated that the balloon catheter shaft was kinked.The balloon catheter was replaced.The case was completed with cryo.No patient complications have been reported as a result of this event.Following analysis of the product/clinical data an out of specification finding was discovered.
|