The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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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Additional information was received on 22-nov-2023.The damage and leaking of the tube was found during preparation of the device.Since the issue was found during preparation and replaced prior to use in the patient, this event was reassessed to not mdr reportable.Therefore, the h6.Medical device problem code of ¿material integrity problem (a04)¿ was removed.Manufacturer's reference number: (b)(4).
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