Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A 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.Note: since no date of death was provided, the best estimate is considered to be (b)(6) 2023.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster inc.'s reference number (b)(4) has two reports: (1) manufacture report number # 2029046-2023-02981 for product code d138501 (unk_smart touch bidirectional).(2) importer report number # 2029046-2023-50020 product code m490008 (unk_smartablate generator).
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It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient experienced esophageal fistula that resulted in death.It was reported the patient was admitted to the emergency room and esophageal fistula was discovered.The patient expired from the injury.Unfortunately, there is no other information available at this time.It is unknown when the original procedure took place, as well as when the patient went to the emergency room and was admitted.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
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