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	10/01/2025
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) procedure with a carto 3 system and the reported map shift with no error message, no patient movement and no cardioversion prior to the map shift occurred.During an atrial fibrillation procedure, while using a jet ventilator, a map shift occurred on the carto 3 system map.No patient movement, no errors displayed, and they were not respiratory gated.There was no a template in use.Although there were no errors present, it was very obvious that there was a 1-2 mm difference in map.They also used ice to continue and complete the procedure.Additional information was received on 03-oct-2025.The issue was seen during ablation.The physician did not perform cardioversion prior to the map shift.The patient did not cough before detecting the shift.The crna stated there were no changes in the patient¿s breathing nor ventilation before the map shift.The patient¿s arm was not moved without changing the patient¿s position on the mattress.The reported map shift issue with no error message and no patient movement is assessed as non-reportable, however, bwi became aware on 03-oct-2025 that the they did not perform a cardioversion prior to the map shift and have reassessed the event as reportable.The awareness date for this record is 03-oct-2025.
Additional Manufacturer Narrative
During an internal review on 28-oct-2025, noted a correction to the 3500a initial under g4.Pma/ 510(k) field as left blank.Should have processed as k231207.The investigation was completed on 18-nov-2025.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.During the procedure, while using a jet ventilator, a map shift occurred on the carto 3 system map.No patient movement, no errors displayed, and they were not respiratory gated.There was no a template in use.Although there were no errors present, it was very obvious that there was a 1-2 mm difference in map.They also used intracardiac echocardiography (ice) to continue and complete the procedure.The carto 3 manufacturer investigated the issue based on the study digital data.It was found that the location of the heart was changed due to the breathing amplitude change.Carto does not compensate for that as the compensation is for body movement as reflected via back patch location movement.The system behavior was correct.The system behaved as expected.According to carto 3 instructions for use: "when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated".The system is ready for use.The complaint history of the system was reviewed.A manufacturing record evaluation was performed for the system #34704, 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: 23409026
• Report Number: 2029046-2025-03604
• Device Sequence Number: 13030697
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: (01)10846835000870(11)180624
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231207
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NGEN SYSTEM.; UNK JET VENTILATOR.; UNK_OCTARAY NAV.; UNK_QDOT MICRO.
• Patient Sex: Unknown