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

Catalog Number	FG540000
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation afib, paroxysmal ablation procedure with a carto 3 and when pacing around the varipulse catheter, the pacing channels selected on the recording system did not match what was being displayed as pacing on the carto 3 system.The reporter stated that when pacing from varipulse 9/10 on the recording system, it was displayed as 7/8 on the carto 3 system.When pacing from varipulse 7/8, it was displayed as 6/7 on the carto 3 system.All the rest were normal.There were no issues with any other bi-poles.It was noted that more lesion touchups had to be performed during the procedure.There was no troubleshooting performed and the procedure was continued and completed without resolution.The varipulse catheter was brand new.There were 30 lesions applied before pacing occurred and the issue was noticed.A direct connect ic out cable was used.Additional information indicated that pacing and ablating simultaneously was not attempted.Nothing was connected to the direct pacing port.The varipulse was plugged into piu port 20a, and pacing was routed using the recording system as normal.Micropace was used as the pacing stimulator.This was planned pacing.No adverse patient consequence was reported.
Additional Manufacturer Narrative
D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.It was confirmed that the issue was not duplicated in next cases.The complaint history of the system was reviewed and no more similar problems were found since the issue occurred.The system is ready for use.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 with serial # (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).
Additional Manufacturer Narrative
Manufacture date has been provided.Therefore, h4.Device manufacture date has been populated.Correction to the initial report: d4.Primary udi number has been updated since the manufacture date has been provided.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: 24716697
• Report Number: 2029046-2026-01004
• Device Sequence Number: 5727020
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: (01)10846835000870(11)100718
• 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): 04/01/2026

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: 02/27/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2010
• 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
• Patient Sex: Unknown