Same case as mdr id# 2134265-2018-60914, 2134265-2018-60917, 2134265-2018-60919.It was reported that hypotension, third degree heart block and perforation occurred.During an ablation procedure for left atrial flutter, a polaris x, an intellamap orion, an intellanav mifi oi lrg curve and intellanav mifi oi std curve were selected for use.The physician mapped the left atrium using the orion mapping catheter while pacing from the coronary sinus (cs) catheter.He removed the orion from the left atrium and replaced it with an intellanav mifi oi lrg curve catheter.After coming on ablation for 3 seconds, the generator gave a d07 excessive temperature error.He changed ablation cables and inspected the catheter tip for evidence of char and did not see any.The real time temperature reading on the ablation generator was giving an internal temperature of 86 degrees.The physician did not reinsert the catheter into the body and replaced it with an intellanav mifi oi std curve ablation catheter and began to ablate.They were able to deliver radiofrequency (rf) without any errors and ablated.They did not notice any abnormal readings in regard to temperature, power and impedance.They ablated for roughly 2 minutes when the patient's blood pressure began to rapidly drop and the patient went into third degree heart block.Transesophageal echocardiography (tee) demonstrated a perforation and compressions were started.The procedure was stopped and resuscitation efforts were continued.The patient was then stable and was admitted to the hospital with the possibility of cardiothoracic (ct) surgery depending on how next few hours went.
|