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.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 male patient with a history of previous pulmonary vein isolation (pvi) ablation procedure in 2015, underwent an atrial fibrillation (afib) ablation procedure on (b)(6) 2020 with a thermocool® smart touch® bi-directional navigation catheter and suffered pulmonary vein stenosis requiring surgical intervention.Post-procedure, the patient underwent surgical intervention for stent placement due to pulmonary vein stenosis resulting from the afib procedure.The patient was reported in stable condition.Prolonged hospitalization was required as a result of the event.The patient¿s condition had improved.The physician¿s opinion regarding the cause of the adverse event is that it was patient condition and procedure related, and due to ablating distal in the pulmonary vein.No biosense webster, inc.(bwi) product malfunction was reported.
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