E1.Initial reporter phone: (b)(6).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 was performed for the finished device number lot 30992682m and no internal actions 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¿ electrophysiology catheter.The patient suffered cerebrovascular accident.They did an afib procedure under general anesthesia.No complication was noted during the procedure, but at the end, when the patient woke up, they suspected a stroke which has been confirmed post-op.Additional information was received.Physician¿s opinion on the cause of this adverse event is none.The patient has been transferred to another center.The outcome of the adverse event was improved.As the patient has been transferred, they lost the follow-up.No need for servicing for the generator and the pump equipment.
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