It was reported that a patient underwent a cardiac ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.A pericardial effusion occurred during a carto 3 procedure.Patient is now stable.A pericardiocentesis was performed.The procedure was not successfully completed.Procedure needed to be cancelled.This adverse event was discovered during use of biosense webster products.Pericardial puncture was performed.A smartablate generator was used during this procedure.An irrigated catheter was used in the event, the flow setting was 17/30 ml.Correct catheter settings were selected on the smartablate generator.No error messages were observed on biosense webster equipment during the procedure.No force visualization features were used, therefore no parameters for stability were used, and there was no additional filter used with the visitag.
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Device investigation details: 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 (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 4.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 ref.# (b)(4).
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