|
Catalog Number FG540000K |
Device Problem
Pacing Problem (1439)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/22/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
E 1.Initial reporter phone : (b)(6).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).
|
|
Event Description
|
It was reported that a patient underwent a cardiac ablation procedure which included a carto® 3 system and an unwanted pacing was being delivered.When pacing was performed using a beeat cs catheter connected to a carto® 3 system and a decanav connected to a 20b, spike appeared after 2 seconds, which was then captured by the intracardiac echocardiogram.Reproducibility was observed and this pacing induced tachycardia.Pacing spikes were present from the time the patient entered the room.They were captured about 1.5 hours after the patient entered the room.The procedure itself was continued and completed without any problems.No adverse patient consequence was reported.
|
|
Manufacturer Narrative
|
Additional information was received on 26-oct-2023.It was reported that the pacing leads were connected to the primary pacing port.The carto® system did not allow pacing from the map catheter ch.1-2 and ablating at the same time.This was a planned pacing and unwanted pacing was being delivered that induced tachycardia.It was also reported that a boston bard lab pacing stimulator was being used during the procedure.Therefore, the concomitant product section was updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
|
|
Manufacturer Narrative
|
Additional information was received and the manufacture date has been provided.Therefore, field h4.Device manufacture date has been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
|
|
Manufacturer Narrative
|
It was reported that a patient underwent a cardiac ablation procedure which included a carto® 3 system and an unwanted pacing was being delivered.When pacing was performed using a beeat cs catheter connected to a carto® 3 system and a decanav connected to a 20b, spike appeared after 2 seconds, which was then captured by the intracardiac echocardiogram.Reproducibility was observed and this pacing induced tachycardia.Pacing spikes were present from the time the patient entered the room.They were captured about 1.5 hours after the patient entered the room.The procedure itself was continued and completed without any problems.No adverse patient consequence was reported.Hardware evaluation details: an investigation was initiated by the manufacturer to investigate the issue.It was found that additional spike is seen, due to pacer malfunction.Carto does not have an internal pacer.The reported issue is related to non-carto device.The system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system # 55575 was reviewed and three additional complaints similar to the reported issue were found.A manufacturing record evaluation was performed for the carto 3 system # 55575, 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).
|
|
Search Alerts/Recalls
|
|
|