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

Catalog Number	FG540000
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system and a map shift with no error message, no patient movement and no cardioversion prior to map shift occurred.A map shift occurred on the carto 3 system as soon as the octaray catheter was removed from the body.They visualized the coronary sinus (cs) catheter shift on the carto 3 system as soon as the octaray catheter was removed from the body.There was no cardioversion or patient movement.There were no errors displayed on the carto 3 system.The farawave catheter was inaccurately displayed on the carto 3 system during the entire ablation.The procedure continued without resolution.No patient consequence was reported.The smartablate and farapulse systems were used for ablation.The petal xml was used.Additional information was received.The approximate difference in map location before and after map shift was 2cm.No changes in the patient's breathing or ventilation before the map shift.The patient¿s head was not raised or repositioned on the pillow.The patient¿s arm did not move without changing the patient¿s position on the mattress.The farawave was connected at the time of the occurrence and was connected through the generator.The shift occurred with both the farawave and with the j&j catheter.
Additional Manufacturer Narrative
The investigation completion details.The system manufacturer investigated the issue based on the study digital data.It was found that the system behavior was correct.Metal levels were high and relevant error appeared.Map shift was a result of working at high metal levels above the specification.The system behaved as expected.The issue is related to user error.The system is ready for use.The history of customer complaints reported during the last year and associated with carto 3 system # (b)(6) was reviewed.No similar additional complaint was found.A manufacturing record evaluation was performed for the system # (b)(6), and no internal actions related to the reported complaint condition were identified.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).

• 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: 23472124
• Report Number: 2029046-2025-03710
• Device Sequence Number: 9478855
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: (01)10846835000870(11)100105
• 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
• Report Date (Section B): 11/04/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2010
• 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: CS CATHETER.; FARAPULSE SYSTEM.; FARAWAVE CATHETER.; OCTARAY CATHETER.; UNK_SMARTABLATE GENERATOR.
• Patient Sex: Unknown