Product event summary: the data files and balloon catheter, 2af284 with lot number 91558 were returned and analyzed.The data files showed at least 6 injections were performed with the returned balloon catheter on the date of the event.The data files confirmed system notice (b)(4) unrelated to the reported issue in two injections on the date of the event.Visual inspection of the balloon catheter showed the device was intact with no apparent issues.The catheter passed the performance test, but inflation showed a kink on the guide wire lumen under the balloon segment.Dissection showed a guide wire lumen kink at 0.93 inches from the tip inside the balloons.In conclusion, the reported issue was confirmed through testing and 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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It was reported that during a cryo ablation procedure, during setup while the balloon catheter push button was maneuvered, and the shaft was kinked.The balloon catheter was replaced.The case was completed with cryo.No patient complications have been reported as a result of this event.The balloon catheter subsequently tested out of specification per the manufacturer's investigation.
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