It was reported that during a cryo ablation procedure, following transseptal puncture, a competitor product was replaced with the manufacturer sheath.Once the sheath was in the left atrium, a competitor product was replaced with the manufacturer mapping catheter, and a 3d electroanatomical map was created using a competitor mapping system.While mapping, it was observed that the patient's blood pressure was low, and as the physician indicated that there was a small baseline effusion, an intracardiac catheter was used to check for any changes in the effusion.While checking, the picture quality of the ice has diminished significantly, however, the physician could not see a change.As the patient's blood pressure remains low, medications were given, and the case continued.After the mapping was complete, the manufacturer mapping catheter was removed, and was inserted into the manufacturer balloon catheter.The balloon catheter was then inserted into the left atrium, via the sheath.It was also reported that there was a possible vasospasm when the left superior pulmonary vein (lspv) was tested with adenosine.The procedure continued, and once the balloon catheter entered the left atrium, and then subsequently moved to the left inferior pulmonary vein (lipv), the pressure transducer that is used to assess pv occlusion was not functioning properly, and the ice picture quality had gotten worse.The physician then made the decision to rely solely on contrast and fluoroscopy for the remainder of the case.The procedure continued, and upon moving the balloon catheter to the right sided veins, the heart border was not moving.At this time, the ice had stopped working completely, and a stat echocardiogram was ordered, and chest compressions were initiated.A decision was then made by the physician and surgical team to open the patient's chest, and a large tear was found.The tear extended from the left superior pulmonary vein (lspv) to the posterior portion of the carina and into the left inferior pulmonary vein (lipv).Despite the surgeon's best efforts, the tear could not be repaired.The patient subsequently died.Additional information reported that the transeptal needle was likely the cause of the injury but without continuous arterial pressure monitoring during the case, there was no way to know without any doubt exactly when the injury occurred.Also, the patient had a laryngeal mask airway (lma) instead of being intubated because of tough patient anatomy.The injury was repaired but the time it took to intubate the patient was the biggest contributor to the injury progressing to death.
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