Product event summary: the device was returned and analyzed.Visual inspection of the catheter showed that the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for 11 injections.The catheter failed the performance test due to frost on the coaxial connector of the catheter.Also, a dissection showed that the catheter was kinked on the guide wire lumen 1.48 inches from the tip.In conclusion, the reported temperature issue was confirmed.The catheter failed the return product inspection due to frost on coaxial connector of the catheter and 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 temperature of the catheter was less than a competitors temperature probe in the esophagus.The balloon catheter continued to be used and the procedure was completed with cryo.The 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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