It was reported that during a cryo ablation procedure, when the sheath was inserted into the femoral vein it appeared to be kinked.The sheath was unable to get into the vein, and was replaced with resolve.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 93057 was returned and analyzed.Visual inspection of the sheath showed a deformation at the tip.In conclusion, the sheath failed the returned product inspection due to a tip damage.The kink was confirmed through testing.If information is provided in the future, a supplemental report will be issued.
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