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

Catalog Number	FG540000
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a varipulse catheter and a carto 3 system and signal noise occurred on all of the ecg and intracardiac (ic) signals without any other monitors available to monitor the patient¿s heart rhythm.It was initially reported that the intracardiac signals from the catheters were attenuated.Each catheter with a sensor was taken out one by one.When the varipulse catheter was taken out, the noise issue resolved.The case was almost over so they did not replace the varipulse catheter.There was no patient consequence.The customer's reported noise on signals is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 4-feb-2026, additional information was received indicating noise was observed on all ecg and intracardiac (ic) signals on both the carto 3 system and the recording system.The physician did not have any other monitor available to monitor the patient¿s heart rhythm.The catheter was in the patient at the time of incident.Based on the new information received, the event was assessed as an mdr reportable 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.Note: for field d4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.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 ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a varipulse catheter and a carto 3 system and signal noise occurred on all of the ecg and intracardiac (ic) signals without any other monitors available to monitor the patient¿s heart rhythm.Device evaluation details: a biosense webster inc (bwi) field service engineer (fse) followed up with the bwi representative and was informed that further cases have been completed without noise issue returning.The bwi representative confirmed that the system performs as intended.The issue was not duplicated.An investigation was initiated by the manufacturer to look into the issue.Data related to the reported issue was requested from the account, but no data was provided.As a result, it was not possible to reproduce or analyze the issue.In addition, the history of customer complaints associated with this specific system was reviewed and it was found that the issue was not reported anymore.System is operational.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 carto 3 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 ref.# (b)(4).

• Brand Name: CARTO 3 SYSTEM
• 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: 24449630
• Report Number: 2029046-2026-00650
• Device Sequence Number: 10052134
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: (01)10846835000870(11)120207
• 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
• Type of Report: Initial,Followup

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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2012
• 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
• Patient Sex: Unknown