Product event summary: the data files for the date of the reported event and balloon catheter, 2af283 with lot 28829, were returned and analyzed.The data files did not show any system notices for 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 1.34 inches from the tip inside the balloons.Pressure test did not show leaks.In conclusion, the reported kink has been confirmed through testing.The balloon catheter, 2af283 with lot 28829, failed the inspection due to a guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.
|