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

Catalog Number FG540000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system, and while mapping the catheter vector shifted inappropriately.All of the catheters were effected and there was a clear map shift.No cardioversion was performed and no errors were displayed on the carto 3 system.The map shift occurred while taking sequential lesions.No errors were discovered.After moving the catheter from inferior to superior along the posterior wall, the medical team noticed a discrepancy in the vector as it was pointing upward.The medical team pulled up catheter snapshots and noticed that the coronary sinus (cs) catheter had moved the same degree and direction as the map catheter had.A remap was done and the case continued.No patient consequences were reported.

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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 26-mar-2024, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system, and while mapping the catheter vector shifted inappropriately.All of the catheters were effected and there was a clear map shift.No cardioversion was performed and no errors were displayed on the carto 3 system.The map shift occurred while taking sequential lesions.No errors were discovered.After moving the catheter from inferior to superior along the posterior wall, the medical team noticed a discrepancy in the vector as it was pointing upward.The medical team pulled up catheter snapshots and noticed that the coronary sinus (cs) catheter had moved the same degree and direction as the map catheter had.A remap was done and the case continued.No patient consequences were reported.Device evaluation details: it was found the user changed significantly the fluoro orientation, as reflected from the patches metal plot.This affected the chest patch position and has similar effect on magnetic sensors in the mapping volume.Error messages on mapper minor metal and octaray minor and warning metal were seen.Map shift was a result of working with high metal levels.The issue is related to user error.Additionally, the patch unit was replaced as part of troubleshooting of the map shift issue and after the device manufacturer's investigation the patch unit not suspected to be part of the map shift issue.The system is ready for use.A manufacturing record evaluation was performed for the system # (b)(6), 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: 18899251
• MDR Text Key: 337670208
• Report Number: 2029046-2024-00833
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1