Product event summary: the data files and the balloon catheter, with lot number 61654 were returned and analyzed.The data files showed at least three applications were performed with this catheter on the date of the event and an unrelated system notice (b)(4) ¿compromised outer vacuum¿ was received.Visual inspection of the catheter showed the device was intact with no apparent issues.Dissection showed a guide wire lumen kink at 1 inch from the tip inside the balloons.Pressure test did not show any leaks.In conclusion, kink issue was confirmed.The 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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It was reported that during a cryo ablation procedure, the balloon catheter appeared to be bent under fluoroscopy.Additionally, on the second freeze, an unknown system notice was received indicating an outer vacuum issue.It was noted to be possibly due to the bend in the catheter.The balloon catheter was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.The catheter was returned to the manufacturer, analyzed, and tested out of specification.
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