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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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It was reported a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the patient experienced cardiac tamponade treated with a pericardiocentesis.After the procedure, a routine echocardiography was performed, during which a pericardial tamponade was discovered.Physician suspects the tamponade to have happened during advancing to the right ventricular outflow tract (rvot).Patient had another medical issue due to which the condition worsened.Physician stated the additional complication was unrelated to the use of biosense webster products and the procedure.No transseptal puncture was performed and no evidence of steam pop.Correct settings selected and no error messages on equipment during procedure.
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On 7-mar-2024, the product investigation was completed as the complaint device was not returned for analysis.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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