Product event summary: the sheath, 4fc12 with lot number 43618, was returned and analyzed.Visual inspection of the sheath showed the shaft was kinked at 6.256 cm from the tip.Functional testing showed the deflection mechanism was working fine and the pull wire was not broken.In conclusion, the sheath failed the return product inspection due to a shaft kink near the tip.
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It was reported that during a cryo ablation procedure, the sheath was kinked proximal to the deflectable curve and was unable to be moved.The sheath was replaced, and the case was completed with cryo.No patient complications have been reported as a result of this event.
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