Same case as mdr id# 2134265-2018-01862, 2134265-2018-01863, and 2134265-2018-01976.It was reported cardiac arrest and cardiogenic shock occurred.Two intellamap orion mapping catheters, a dynamic xt steerable diagnostic catheter, and a woven diagnostic catheter were selected for use during a ventricular tachycardia ablation procedure.During ablation with another manufacturer¿s ablation catheter, the patient experienced cardiac arrest and cardiogenic shock.Multiple external defibrillations/shocks were administered, as well as advanced life support including cpr and medications.The patient ultimately received circulatory assist devices (a heart pump and extracorporeal membrane oxygenation (ecmo)) before being transferred from the ep lab.The ep staff later reported that the patient required vascular surgery the next day as a result of the ecmo device.The patient appeared to be stabilized but in critical condition.Noise with the orion catheters had been noted; however, there was no information alleging the noise caused or contributed to the complications.The orion catheters had been removed from the patient¿s body for two and a half hours prior to onset of the patient¿s complications.The dynamic xt was in the patient when the complications occurred, and the woven catheter was positioned in the right ventricle thorough out the procedure.The physician was uncertain as to the cause of the cardiac arrest and cariogenic shock, but commented that the patient was likely sicker than previously considered prior to the procedure.
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