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Catalog Number FG540000 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2024 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent an atrial fibrillation ablation procedure with a carto 3 system and a map shift occurred on one monitor.The issue was addressed by rebooting and reinitializing.After the reboot, the issue resolved.No patient consequences were reported.
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Manufacturer Narrative
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The hardware investigation has begun but it has not been completed at this time.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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Manufacturer Narrative
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On (b)(6) 2024, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a carto 3 system and a map shift occurred on one monitor.The issue was addressed by rebooting and reinitializing.After the reboot, the issue resolved.No patient consequences were reported.Device evaluation details: the manufacturer investigated the issue.It was found that there are no evidence for map shift.System behaved as expected.The issue was not duplicated since the time it occurred.It was also reported that the carto 3 system display was only displayed on one monitor.The system was rebooted and the issue resolved.The issue was not duplicated since then.The complaint history of the system was reviewed and no more similar problems to the aforementioned ones were found since their reported occurrence.The system is ready for use.A manufacturing record evaluation was performed for the system #(b)(4), and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Search Alerts/Recalls
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