Product event summary: the sheath, 4fc12 with lot number 70892, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Deflection worked as per specification.The pressure test did not show any leak, no bend or kink could be confirmed for the returned sheath.The test dilator was inserted without any issue.In conclusion, the sheath kink was not confirmed.The sheath passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.
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It was reported that during a cryo ablation procedure, the sheath tip could not pass through the interatrial puncture site, and it was observed that the joint between the sheath and the 'expansion strip' was shaped like a bend.The sheath was replaced with resolve, and the case was completed with cryo.No patient complications have been reported as a result of this event.
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