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

Catalog Number	FG540000
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.E1.Initial reporter phone: (b)(6).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 there was a burn smell from the patch unit.Patch number 2 of the green cable became stripy in intermittence during the procedure.Managed to finish by moving the cable slightly.No harm on patient.Additional information was received on 31-oct-2025 indicated that there was a burn smell from the patch unit.The patch was no longer visible.Tried with another pu which solved the issue.The event is considered non-reportable, however, bwi became aware on 31-oct-2025 of a burn smell from the patch unit and have reassessed this issue as reportable.The awareness date for this record is 31-oct-2025.
Additional Manufacturer Narrative
H4.Device manufacture date and d4.Primary udi number have been added.During an internal review on 25-nov-2025, noted a correction to the 3500a initial under h11.Additional manufacturer narrative as in error included, ¿d4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.¿ it should have stated, ¿d4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available." if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.It was reported patch number #2 of the green patch sensor cable became stripy in intermittence during the procedure.No harm on patient, managed to finish by moving the cable slightly.In addition, it was reported that the customer mentioned burn smell from the patch unit.The patch was no longer visible.The customer tried another patch unit which solved the issue.A replacement patch unit was requested.The investigation was completed on 21-jan-2026.It was confirmed that the reported issue was resolved by using another patch unit.The bwi field service representative confirmed that a replacement patch unit was provided to the customer.Issue was resolved.The system was ready for use.The suspected patch unit associated with this complaint has been returned to the manufacture for further analysis.Burn smell issue: during investigation, no burning signs were detected on the patch unit.The burn smell from the patch unit issue was not confirmed.No failure was found with patch unit.Green patch #2 issue: during investigation it was found that the yellow patch sensor cable was faulty and caused reported issue.It was confirmed that the issue was resolved by replacing the yellow patch sensor cable with a replacement one.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.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.Explanation of codes: investigation findings: electrical problem identified (c02) / investigation conclusions: cause traced to component failure (d02) / component code: hub ((b)(6)) were selected as related to the customer¿s reported ¿patch number #2 of the green patch sensor cable became stripy in intermittence¿ issue.In addition, biosense webster inc.Analysis finding of the ¿yellow patch sensor cable was faulty¿.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) / component code: hub ((b)(6)) were selected as related to the customer¿s reported ¿burn smell from the patch unit¿ issue.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: 23612377
• Report Number: 2029046-2025-03870
• Device Sequence Number: 9259054
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: (01)10846835000870(11)130319
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 01/21/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 11/26/2025; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2013
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown