Product event summary: the balloon catheter, 2af284 with lot number 56618, 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 for 4 injections.The catheter passed the performance test and electrical integrity as per specification; but dissection and pressure test revealed a guide wire lumen kink at 1.02 inches from the tip inside the balloons.In conclusion, the balloon catheter failed the returned product inspection due to a guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.
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