MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent a pulmonary vein isolation (pvi) ablation procedure with a carto® 3 system.There was a map shift.During ablation, they had map shifts.The bwi sales consultant was not there but she said that apparently, they hadn't initialized yet but it should have still worked.They did a new map and started a new ablation after that.The issue didn't come back after that.The procedure was completed.There were no patient consequences, there was a 1-hour delay reported.V.2; full version unknown.Additionally it was reported that before the procedure, during the preparation, they had an issue with the location pad.All 6 green and yellow patches were not visible.They restarted the patient interface unit (piu) and workstation, and all 3 yellow patches were visible.However, all 3 green patches were still not visible.They changed the green patch cable, and it solved the issue (the caller wasn't sure if the replacement was a brand-new cable or a backup).The caller was not sure if the cable was still available.The bwi sales consultant was not sure about the green patch replacement, she said she will check with the physician.In physician¿s opinion, the delay did not contribute to a death or a serious injury to the patient.No intervention was required due to the delay.The map shift was discovered during ablation.The ablation points (visitags were not where there are supposed to be).The system did not provide an error.The issue was seen during ablation.The approximate difference in catheter location before and after map shift was 1cm.The physician did not perform cardioversion prior to the map shift.The patient did not move before detecting the shift.Map shift is mdr-reportable.C-3 location patch issue is not mdr-reportable.

Manufacturer Narrative

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.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

On 26-jan-2023, the product investigation was completed.It was reported that an unknown patient underwent a pulmonary vein isolation (pvi) ablation procedure with a carto® 3 system.There was a map shift.Device evaluation details: the issue was investigated by device manufacturer.The data received does not match the description of the course of the case.As result, it was not possible to reproduce or analyze the issue.The root cause of the reported map shift issue was not determined.The history of customer complaints reported during the last year associated with carto 3 system # 29126 was reviewed.No additional complaints for the same issue were found.A manufacturing record evaluation was performed for the carto 3 system # 29126, 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).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16012125
• MDR Text Key: 308556596
• Report Number: 2029046-2022-03187
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1