Product event summary: the 2af284 balloon catheter with lot 00514 was returned and analyzed.Visual inspection showed the balloon catheter was intact with no apparent issues.Smart chip verification indicated the catheter was used for 12 injections, the balloon catheter passed the performance test and electrical integrity as per specification; impedance was also within specification.The inflation test revealed a kink under the balloon segment.Further dissection showed a guide wire lumen was kinked at 1.39 inches from the tip.In conclusion, the balloon catheter failed the returned product 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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