E1 initial reporter phone: (b)(6).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 was performed for the finished device (b)(6) number, and no internal action related to the complaint was found during the review.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 which included the use of a thermocool® smart touch® sf bi-directional navigation catheter experienced cardiac tamponade treated with a pericardiocentesis, extended hospitalization and a surgical intervention.Transseptal puncture was performed by rf (radiofrequency) needle and ablation performed.No evidence of steam pop.After pvi (pulmonary vein isolation) was completed, lpv (left posterior ventricular) reoccurrence was confirmed.At 150 minutes after the start of the procedure, a decrease in blood pressure was observed and pericardial effusion was confirmed by intracardiac echocardiography.Pericardial effusion was removed by drainage, and hemodynamic stability was confirmed.The patient required extended hospitalization because of open surgery and has since been discharged from the hospital.
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