It was reported that during a cryo ablation procedure, when the sheath was advanced into the left atrium and the dilator was removed, a shaft kink was seen via x-ray.The sheath was replaced, resolving the issue.The case was completed with cryo.No patient complications have been reported as a result of this event.
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Product event summary: the sheath 4fc12 with lot number 0009952797 was returned and analyzed.Visual inspection showed the shaft was kinked at 2.8 inches from the tip.The shaft tip was intact with no apparent issues.In conclusion, the reported kink issue was confirmed through testing.The sheath failed the returned product inspection due to a shaft kink.If information is provided in the future, a supplemental report will be issued.
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