Device investigation details: 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 (mre) cannot be conducted because no lot number was provided by the customer.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.# (b)(4).
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It was reported that a patient underwent a left idiopathic ventricular tachycardia (idvt) ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced phrenic nerve injury.Before burning, pacing captured the phrenic nerve.However, after burning, they were not able to capture the phrenic nerve.The patient was able to breathe when they woke up.It was unclear whether the phrenic nerve was temporarily or fully damaged.They went epicardial around the left ventricle (lv).The second time they paced after ablation they were not able to capture the phrenic nerve.The adverse event was confirmed by pacing.No medical intervention provided.Patient is stable additional event information was received indicating the physician's opinion on the cause of the adverse event is combination of procedure and patient condition.Patient improved.Patient is doing well post procedure.No signs of phrenic damage post procedure but never performed any post procedure testing to confirm if it truly did recover.
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