Product event summary: the device and data files were returned and analyzed.Data files showed at least 10 applications were performed with the catheter on the date of the event.Also, a system notice was received indicating that the refrigerant delivery path was obstructed ((b)(4)) was triggered on third applications.Visual inspection of the catheter showed that the device was intact with no apparent issues.The catheter passed the performance test as per specification.The dissection/pressure test showed a guide wire lumen kink inside the balloon 1.3 inches from the tip of the catheter and there were no leaks.In conclusion, the reported shaft kink was confirmed through testing.The catheter failed the return 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 push lever of the balloon catheter could not be pushed back, when attempting to retract the balloon catheter.The lever had to be manually pushed back, and the procedure continued.Additionally, the balloon shaft was noted to be kinked under fluoroscopy.The physician opted to not replace the balloon catheter.The case was completed with cryo.The balloon catheter was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.
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