Product event summary: the balloon catheter, 2af283 with lot number 68386, was returned and analyzed.Visual inspection of the catheter showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for seven injections.Dissection showed a guide wire lumen kink at 1.0 inch from the tip inside the balloons.Pressure test did not show leaks and the steering mechanism was functioning properly.In conclusion, the balloon catheter failed the inspection due to the guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.
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