During a procedure a smartfreeze was selected for use.It was reported that preparation was according recommended procedural steps.The balloon catheter was unpacked, connected with the electrical cable and cryo cable to the smartfreeze console, then the vacuum was turned on.The polarx catheter and polarmap were submerged into saline.The physician prepared the balloon per instruction, positioned the balloon in lspv and started with ablation.Several seconds later the console displayed the error 2 - 00000008-1: refrigerant flow obstruction detected.Troubleshooting was performed, the cryo cable was disconnected and reconnected, the vacuum was turned on again.But when the ablation started the error appeared.Troubleshooting process was repeated but issue persisted.The cryo cable was replaced, the connections were reestablished, the vacuum was turned on and the procedure continued, but when the ablation was started the same error was displayed.Troubleshooting process was repeated but issue was still present.The catheter was replaced, all steps were repeated, but when ablation was started the error was displayed again.The patient was not harmed or in danger during the troubleshooting period.The procedure was cancelled due to the error displayed.The device is expected to be returned.
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