Product event summary: the data files and balloon catheter, 2af283 with lot number 96407 were returned and analyzed.The data files showed that at least 23 injections were performed on the date of the event without triggering any system notice.Visual inspection of the balloon catheter showed the catheter was intact with no apparent issue.Smart chip verification showed that the catheter had been used for 15 injections.Performance test did not show any system notice.The catheter passed the deflection test as per specification.Dissection showed that guide wire lumen kinked at 1.3530 inches from the tip of the catheter.In conclusion, 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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It was reported that during a cryo ablation procedure, there was difficulty handling the balloon due to deformation of the curvature.The case was completed with cryo.No patient complications have been reported as a result of this event.The device was returned to the manufacturer, analyzed, and tested out of specification.
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