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CLOSER LOOK: Dr. Doshi leans over to read information off the computer monitor as he controls Hansen Medical’s Sensei robotic catheter system during operation on patient Craig Schumacher. (Register photo by Leonard Ortiz)
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It was recently reported to the FDA that a patient died during a Sensei atrial fibrillation ablation procedure when his lwft atrium was perforated. According to the warning label affixed to each system “\
” The safety and effectiveness of this device for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias including atrial fibrillation, have not been established. ”
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1196028