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E.1 initial reporter facility name (cont): (b)(6).E1.Initial reporter phone: (b)(6).The biosense webster, inc.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.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 a cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and during the procedure, the device (including port, luer hub) was not irrigating.A second device was used to complete the operation.There was no adverse event reported on patient.Additional information received on (b)(6) 2024 indicated that the issue was noted during use on patient.With the additional information, this event is being considered mdr reportable with an awareness date of (b)(6) 2024.
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