Product event summary: the balloon catheter 2af284 with lot 00528, was returned, and analyzed.Visual inspection of the catheter showed that the device was intact with no apparent issue.Smart chip verification indicated the catheter was used for 19 injections.The catheter passed the performance test.The dissection and pressure test showed a guide wire lumen kink at 1.3 inches from the tip of the catheter.In conclusion, the balloon catheter failed 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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