The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
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It was reported that a patient underwent an atrial fibrillation ablation procedure using a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cerebrovascular accident that resulted in intubation of the patient.It was reported that the patient experienced a stroke.The stroke possibly occurred during the procedure, but it was uncertain.During the procedure, the bag for the agilis sheath was changed and air was introduced into the line.St elevations were noted on the electrocardiogram (ecg).The physician physically noticed bubbles in the line when the agilis sheath was aspirated/pulled back with the syringe.The physician was able to pull the air out and the st elevation resolved on its own.The procedure continued and was completed.The patient woke up and fully recovered (this was (b)(6) 2023).On (b)(6) 2023, it was reported the patient had a stroke and was fully intubated.Stroke was confirmed on magnetic resonance imaging (mri).The physician's opinion on the cause of this adverse event was that there was an error in procedure.The line for the agilis sheath should have been flushed when changing the bag.No pump malfunction reported.
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