On 9-nov-2023 the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 ref.# pc-001463360.
|
It was reported that a patient underwent a non-ischemic ventricular tachycardia ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the patient experienced heart failure and st elevations that required ecmo (extracorporeal membrane oxygenation) and heart catheterization.Endocardial mapping was done in the left ventricle (they went transseptal) and the ablation was done epicardially.When getting ready to finish the case it was observed that the right ventricle wasn't contracting much and the physician had to call in the ecmo team.Caller stated the physician said the patient was in biv (bi-ventricular) heart failure.The physician wanted an impella placed so that it would support blood pressure when trying to map the ventricular tachycardia (vt).At the end of the case when they did call the ecmo team the patient did have st elevations on the ecg and now the patient also needs a cath.Intervention provided also included "defibrillator program back on." device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).
|