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.Biosense webster inc.'s reference number (b)(4) has two reports: (1) manufacture report number #, for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) importer report number # 2029046-2023-50018 for product code m490007 (smartablate¿ system rf generator (us)).
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It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure which included the use of a thermocool® smart touch® sf bi-directional navigation catheter and smartablate¿ system rf generator, and experienced an esophageal fistula and received intervention; however, details are unknown.The only information provided was that the patient suffered an esophageal fistula after the procedure but could not confirm when it happened and any details on how the injury was discovered.The last known status of the patient was stable.No other details or information were provided.The catheter worked as expected with no issues during the procedure.Additional information was provided.The adverse event occurred after the procedure.The physician¿s opinion on the cause of this adverse event was that it was procedure related.Patient has improved.
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