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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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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Procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac arrest and ultimately passed away.It was reported by the biosense webster (bwi) representative that after the isvt procedure was successfully completed, the patients pressure dropped, and the patient went into pulseless electrical activity (pea).No effusion was seen with the intracardiac echocardiography (ice) catheter.A code was called, and cardiopulmonary resuscitation (cpr) was performed with defibrillation several times as the patient went in ventricular fibrillation.An impella catheter was inserted.Cpr and defibrillation were performed for at least an hour before the code was called and the patient was deemed expired.Catheters were discarded.
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