|
Model Number FG540000 |
Device Problem
Display or Visual Feedback Problem (1184)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/06/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and a map shift no error message with no patient movement and no cardioversion performed.Initially it was reported that there was a map shift of about 1/5 of a centimeter and there were no error messages on the carto® 3 system.They continued by remapping and drawing new contours and that took care of the problem.The procedure continued with no other issues.They requested a biosense webster field service engineer on-site follow-up to evaluate and repair the carto® 3 system.Additional information was received on (b)(6) 2023.The map shift was discovered as the catheters no longer lined up with the fast anatomical mapping (fam) shell/volume.The issue was seen both during mapping and ablating.The appropriate approximate difference in the catheter location before and after the map shift was 0.5 ¿ 1cm.There was no movement detected on the patient and no errors indicating movement on the carto® 3 system.This event was originally considered non-reportable, however, bwi became aware of additional information stating that there was no movement detected on the patient and have reassessed the event as mdr reportable for a map shift no error message with no patient movement and no cardioversion performed.The reportable awareness date is (b)(6) 2023.
|
|
Manufacturer Narrative
|
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).
|
|
Manufacturer Narrative
|
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 14-jun-2023, noted a correction to the 3500a follow-up #1 as it stated, ¿the product investigation was completed on 22-may-2022.¿ however, it should have stated, ¿the product investigation was completed on 22-may-2023.¿.
|
|
Manufacturer Narrative
|
The product investigation was completed on 22-may-2022.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system.It was reported that there was a map shift of about 1/5 of a centimeter and there were no error messages on the carto® 3 system.They continued by remapping and drawing new contours and that took care of the problem.The procedure continued with no other issues.The biosense webster, inc.Field service representative re-imaged the pc and the system is working properly and is back in service.The issue was investigated by the device manufacturer under investigation request.It was found that the reported map shift resulted from mid metal levels at ambient of low metal.The issue is related to defect.The defect is being handled per defect management process.The complaint history of the system was reviewed.A manufacturing record evaluation was performed for the system # (b)(6), and no internal actions related to the reported complaint condition were identified.An internal corrective action has been opened to investigate.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
|
|
|