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It was reported that a (b)(6)male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® bi-directional navigation catheter and the patient suffered pyrexia, hypothermia and pneumomediastinum and later died on an unknown date.On (b)(6) 2022, the patient underwent an atrial fibrillation (afib) ablation procedure.After discharge from the hospital, about 3 weeks after discharge, the patient was brought to the hospital by ambulance due to pyrexia and hypothermia.The patient was treated with antibiotics and other drugs but died several days later.The cause of death is unclear, but hypothermia is likely.An magnetic resonance imaging (mri) scan revealed pneumomediastinum, but the patient died of shock.No treatment was performed for the for pneumomediastinum.The pneumomediastinum was thought to be caused by something other than the heart allowing air in.It was not considered serious, and it did not lead to an esophageal fistula.Although hospitalization was not prolonged after the ablation procedure, hospitalization was required for hypothermia and pneumomediastinum three weeks after ablation procedure discharge; the patient was subsequently hospitalized until death.The bwi-representative reviewed the ablation procedure data with the physician due to the possibility of injury to the esophagus.The ablation near the esophagus was conducted with an ablation index (ai) value that was not high.Therefore, it was considered unlikely that the cause of the adverse event was ablation.The physician thought there was a possibility that the patient esophagus was injured when the esophageal catheter was inserted or that the patient¿s lungs were injured with bipap (non-invasive ventilation).There is no firm evidence of esophageal injury.According to the physician, the cause was unrelated to the ablation and there was no causal relationship with the product; not related with a bwi product malfunction.Although it was not a serious complication under normal circumstances, the condition of the patient was not good at the time.The physician¿s opinion on the cause of this adverse event is probably related with the procedure.During ablation there was no injury or adverse event, but during ablation temperature was 25, imp100 approximately 110o power 35 or 40w.A smartablate generator was used in the case in power control mode and service for the unit was not needed.The correct catheter settings were selected on the smartablate generator and the pump was switching from low to high flow during ablation.No error messages were observed on biosense webster equipment during the procedure.A temperature sensor catheter was placed in the esophagus and temperature was monitored during the ablation procedure.The carto® 3 system did not indicate to re-zero the catheter.Force visualization features used were dashboard & graph taken from a computed tomography (ct).The visitag module parameters for stability were range: 2mm, time: 3sec, force over time (fot) 25% and 3g and ablation index.
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Device investigation details: additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30642590l number, and no internal actions related to the complaint were found during the review.Date of death is unknown, as such, it has been populated with (b)(6) 2022 as a best estimated date of death.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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