Product event summary: the balloon catheter, 2af283 with lot number 17108 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 14 injections.The catheter failed the performance test due to system notice 50032 ¿the safety system detected a compromised outer vacuum.¿ dissection and pressure test showed at leak at the check valve in the y-block.Additionally, a guide wire lumen kink was seen at 1.30 inches from the tip.In conclusion, the reported kink was confirmed.The balloon catheter failed the returned product inspection due to the kink on the guide wire lumen.If information is provided in the future, a supplemental report will be issued.
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