Product event summary: the data files and balloon catheter 2af284, with lot number 81592 were returned and analyzed.The data files showed an unrelated system notice (b)(4) "electrical component failure" at application 3 with the returned balloon catheter which was used for 3 injections.Additionally, 13 applications were performed with a different balloon catheter without any issue on the date of the event.Visual inspection of the balloon catheter showed the device was intact with no apparent issues.Dissection showed a guide wire lumen kink at 1.4 inches from the tip inside the balloons.Pressure test did not show leaks.After dissecting the catheter, the pull wires were inspected, and no issues were noticed.In conclusion, the reported steerability issue was confirmed through testing but it was caused by the guide wire lumen kink.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.
|
It was reported that during a cryo ablation procedure, the pull wire of the balloon catheter malfunctioned.The balloon catheter was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.The device was returned to the manufacturer, analyzed, and tested out of specification.
|