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

Catalog Number	FG540000
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional 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.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 and a map shift showing the coronary sinus (cs) catheter was outside of the mapping shell, after several pulsed field ablations (pfa).The location pad was off during the pfa applications.There was no adverse patient consequence that was reported.Additional information was provided, and it was indicated that a farawave catheter did not line up with the geometry.The issue was seen during ablating.The approximate difference in map location before and after map shift was a few millimeters.The physician did not perform cardioversion prior to the map shift.The patient did not move nor cough before detecting the shift.There were no changes in the patient's breathing or ventilation before the map shift.The patient's head was not raised nor repositioned on the pillow.The patient's arm was not moved without changing the patient's position on the mattress.A farawave (non-j&j catheter) was connected at the time of occurrence.The map shift occurred with both the farawave catheter, as well as with the j&j catheter.
Additional Manufacturer Narrative
The hardware investigation was completed on 15-feb-2026.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 and a map shift showing the coronary sinus (cs) catheter was outside of the mapping shell, after several pulsed field ablations (pfa).The location pad was off during the pfa applications.There was no adverse patient consequence that was reported.Hardware evaluation details: the carto 3 manufacturer initiated an investigation to look into the issue based on the study digital data.According to the data, it was found that the issue is related to a software defect.The defect is being handled per defect management process; however, this does not impede safe operation of the system.The history of customer complaints reported during the last year associated with carto 3 system #3036534 was reviewed.No similar complaints were found.The manufacturing record evaluation was performed on carto 3 system #3036534, 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
• Common Device Name: 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23369090
• Report Number: 2029046-2025-03536
• Device Sequence Number: 13041254
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: (01)10846835000870(11)230206
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 02/15/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FARAPULSE¿ GENERATOR.; FARAWAVE CATHETER.; UNK CORONARY SINUS (CS) CATHETER.
• Patient Sex: Unknown