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Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 30960888l and no internal action related to the complaint was found during the review.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 (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac perforation that required pericardiocentesis and cpr.It was reported that a cardiac tamponade and a left atrial perforation occurred during a persistent afib procedure.They reported that the physician felt a steam pop on the catheter during ablation.The patient's blood pressure began to drop.The cardiac tamponade was confirmed with intracardiac echocardiography (ice).The medical intervention provided was that they performed cpr.The patient regained their blood pressure and a pericardiocentesis was performed.They reported that about 1400 ccs of fluid were removed, 700 of which were auto transfused via cell saver.The patient was in stable condition.The procedure was aborted.Additional information was received.The adverse event occurred on (b)(6) 2023.It was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was that it was procedure related.Interventions provided was cpr, pericardiocentesis, and cell saver with auto transfusion.Outcome of the adverse event was improved.Patient required extended hospitalization because of the adverse event for observation.Patient was transferred to another facility capable of cardiothoracic care.Graph, dashboard, vector was used.Visitag module was used, parameters for stability used was 2/3.Additional filter used with the visitag was fot 25/3.Index was used.The steam pop issue occurred at the end of the procedure.Generator parameters (power or temperature control mode) and thresholds (temperature cut off and power cut off) were power mode 50watts nominal impedance cut 250.Impedance spike at 100 ohms; 50watts, no over temp or impedance cut from the machine.Physician did not inform as to when he may have felt the steam pop.The length (minutes and seconds) of the ablation cycle when the pop was observed at the same tip position was unknown.No errors reported by the biosense webster systems.
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