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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 03/08/2024 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and the map shift had no error message, no patient movement and no cardioversion performed.While mapping in the left and right atriums, there was a map shift on the carto® 3 system.Between the last case and this case, the patient interface unit (piu) and workstation were shut down.The procedure continued.There was no patient consequence reported.Additional information was received on 12-mar-2024.There was no error on the system.No cardioversion was performed during the case and no patient movement was noticed.The map shift was discovered when ablation started, the catheter vector did not correspond to the expected vector at the location seeing on the map.A cs snapshot was also used to notice the shift.The approximate difference in catheter location before and after map shift was about the distance between the tip and the proximal electrodes on the smarttouch sf catheter.The event was originally considered non-reportable, however, bwi became aware of additional information stating the map shift had no error message, no patient movement and no cardioversion was performed on 12-mar-2024 and have reassessed the map shift issue as reportable.Therefore, the awareness date for this reportable record is 12-mar-2024.
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Manufacturer Narrative
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The hardware investigation has begun but it has not been 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.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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Manufacturer Narrative
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The investigation was completed on 08-may-2024.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system.While mapping in the left and right atriums, there was a map shift on the carto® 3 system.Between the last case and this case, the patient interface unit (piu) and workstation were shut down.The procedure continued.There was no patient consequence reported.It was confirmed that the issue was resolved by reimaging the carto 3 workstation.The system is ready for use.An investigation was initiated by the manufacturer to investigate the issue.It was found that the reported issue is related to patient move ¿ user error.According to carto 3 instructions for use: "when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated." the manufacturing record evaluation was performed for the carto 3 system # 34744, and 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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