The device has been reported as discarded, 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 procedure using a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cardiac arrest that required cpr and heart catheterization.The patient had just been put on amiodarone (antiarrhythmic), the patient's blood pressure severely dropped, and patient went into cardiac arrest.The recording system confirmed lack of heartbeat and the blood pressure dropping.Cardiopulmonary resuscitation (cpr) was provided, as well as a left heart catheterization into the heart.The patient's blood pressure returned to normal, and the patient stabilized.The physician hypothesized that cardioversion combined with starting the amiodarone caused the blood pressure drop and ultimately to the cardiac arrest.The ablation catheter was in the left atrium of the body during the procedure.
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