Product event summary: the device was returned and analyzed.Visual inspection of the sheath showed that the shaft was kinked and twisted 1.3 inch from the tip of the shaft.The deflection was out of order.A dissection test did show the pull wire was intact.In conclusion, the reported steering mechanism issue was confirmed through testing.The sheath the performance test due to a shaft d istortion and 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 steering mechanism of the sheath was out of order.The case was able to be 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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