It was reported that during a cryo ablation procedure, after the balloon catheter was unable to advance through the sheath, the sheath showed damage and was folded.The balloon catheter and sheath were replaced which resolved the issue.The case was completed with cryo.No patient complications have been reported as a result of this event.
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The 4fc12 sheath with lot 0010055545 was returned and analyzed.Visual inspection of the sheath showed the shaft was kinked and ribbed 2.2 inches from the tip.The kink could cause deflection, steerability, or insertion difficulties.The reported kink was confirmed through testing.In conclusion, 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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