Product event summary: the balloon catheter, 2af284 with lot number 06839, 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 8 times.The catheter passed the performance test; electrical integrity and impedance were also within specification.Dissection showed a guide wire lumen kink at 0.926 inches from the tip inside the balloons.Pressure test did not show leaks.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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