Product event summary: the balloon catheter, 2af283 with lot number 95559, was returned and analyzed.Visual inspection of the balloon catheter showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used 29 application.System notice (b)(4) ¿the safety system has detected fluid in the catheter and stopped the injection¿ was triggered when catheter connected to the console.Dissection / pressure testing showed a double balloon breach.In conclusion, the balloon catheter failed the returned product inspection due to the double balloon breach.If information is provided in the future, a supplemental report will be issued.
|