Event summary: the returned patient data files showed at least six applications were performed with catheter 2af284/91556 on the date of event with no issue.Failure file did not show any system notice triggered on the event date.This is a clinical issue encountered during cryoablation procedure.Visual inspection of the sheath, 4fc12 / 04473, showed a deformation at the tip of the shaft.Functional testing of the sheath showed deflection worked as per specification.In conclusion, this is a clinical issue (bp, hr, hemorrhage, arrest) encountered during a cryoablation procedure.The sheath failed the returned product inspection due to a shaft tip deformation.If information is provided in the future, a supplemental report will be issued.
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