E 1.Initial reporter address line 2 (cont): sydäntoimenpideyksikkö/h2.01.It was indicated that the device is not available for return, 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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It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required pericardiocentesis, drain and surgical intervention and prolonged hospitalization.It was reported that the patient got pericardium fluid during the procedure.Pericardium drain was inserted, and patient was taken to the operating theatre for surgery.Additional information was received.It was reported that the physician's opinion on the cause of this adverse event is the procedure.Patient had a pericardium drainage and "thorakotomia".Patient fully recovered but required extended hospitalization.Transseptal puncture was performed.No ablation was performed prior to noting the pericardial effusion.No steam pop occurred.The event occurred during the ablation phase.The perforation was located in the right ventricle.No error messages observed on biosense webster equipment during the procedure.
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