Product event summary: the electrophysiology (ep) catheter 227f3 with lot number 56710 was returned and analyzed.Visual inspection of the catheter showed the shaft was broken above the electrodes at 3 different places, the verification of the smart chip file showed that this catheter was used for one injection.The visual inspection showed that the catheter was intact with no apparent issues.Additional tests were unable to be conducted with the catheter as it had been damaged.All electrodes are tight and sealed.The tip of the catheter was also intact on the detached part of the shaft.In conclusion, the broken shaft issue was confirmed.The ep catheter failed the returned product inspection due to shaft breakage.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 steerability of the electrophysiology (ep) catheter was not as expected.In an attempt to straighten out the ep catheter, the tip of the catheter broke off and a system notice was received indicating that the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled.The broken tip remained in the sheath during removal.The case was aborted.No patient complications have been reported as a result of this event.
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