Following a cardiac ablation procedure on (b)(6) 2015, the patient experienced a myocardial infarction.Two weeks following ablation of the cavotricuspid isthmus using a tacticath quartz ablation catheter, the patient presented with chest pain.On (b)(6) 2015, a coronary angiogram was performed, which revealed infarction of the coronary artery near the cavotricuspid isthmus.A stent was placed at the site of infarction in the coronary artery and the patient is now doing well.
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(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis; however, the log files from the tactisys quartz system were returned.Review of the log files revealed the device functioned as intended and there were no contributing anomalies.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.Per the ifu, myocardial infarction is a known risk during ablation procedures.
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