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 was performed for the finished device number lot 31205268l and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.E1.Initial reporter phone: (b)(6) 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 common atrial flutter ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac arrest / heart failure that required iabp (intra-aortic balloon pump).It was reported that tachycardia had been occurring before the procedure.Blood pressure was as low as approximately 70 from the time of admission and discharge, which was considered to be due to tachycardia, but it remained low after the procedure.After the patient returned to the ward, ejection fraction (ef) decreased to 10% or less, and iabp was conducted.The physician considered the cause would be the fact that cardiac failure had progressed considerably.No abnormalities observed prior to or during use of the product.The physician's opinion on the cause of this adverse event is patient condition.The physician considered the cause would be the fact that cardiac failure had progressed considerably.Patient recovered.
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