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

Catalog Number	FG540000
Medical Device Problem Codes	Signal Artifact/Noise (1036); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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 a supraventricular tachycardia (svt) ablation procedure with a carto 3 and there was noise on the ecg cable signals.During the setup of the case, there was noise on the ecg cable signals and an error #1201 - ecg limb lead disconnection.They checked all the connections, and everything was securely attached.The cable was replaced, and the problem was resolved.The case continued.No adverse patient consequence was reported.Initially, the event was assessed as not mdr reportable.However, additional information was received on 24-oct-2025, and it was indicated that the signal interference (noise) was observed on both the carto® and recording system.The physician did not have any intact ecg signal available to monitor patient heart rhythm.This was not the first use of the involved bs ecg cable.With the additional information, the event is now considered mdr reportable.
Additional Manufacturer Narrative
It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a carto 3 and there was signal interference (noise) observed on both the carto® and recording system, without any intact electrogram (ecg) signal available to monitor patient heart rhythm.The ecg bs cable was replaced, and the issue was resolved.The procedure continued.A replacement ecg bs cable was requested.It was confirmed that the requested ecg bs cable was delivered to the customer.The system is ready for use.The suspected ecg bs cable was sent to the manufacturer for investigation.It was found that the issue was caused by a disconnection in the right arm limb.The history of customer complaints reported during the last year and associated with carto system # (b)(6) was reviewed.No similar additional complaint was found.The manufacturing record evaluation was performed on carto 3 # (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 ref.No: (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: 23612059
• Report Number: 2029046-2025-03868
• Device Sequence Number: 18636484
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: (01)10846835000870(11)141202
• 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): 11/20/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 11/23/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2014
• 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: BS CABLES SET,2M TRUNK + LEADS.; UNK_NGEN RF GENERATOR.
• Patient Sex: Unknown