MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO3 EXTERNAL REFPATCH 6PACK; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Catalog Number	CREFP6
Medical Device Problem Codes	Expiration Date Error (2528); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there were some inconsistences between the reference patch carto 3 device and the package label.It was reported that when the package was open, it was found that the lot and expiration date on the device were inconsistent with those on the package and there were mixing of expired materials.The devices were not used on the patient.
Additional Manufacturer Narrative
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 there were some inconsistence between the reference patch carto 3 device and the package label.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A device history record review was performed for the finished device lot number ll027285 and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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: CARTO3 EXTERNAL REFPATCH 6PACK
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): LEAD-LOK INC; 814 airport way; sandpoint ID
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23493849
• Report Number: 2029046-2025-03741
• Device Sequence Number: 15694614
• Product Code: DQK
• UDI-Device Identifier: 20846835000129
• UDI-Public: (01)20846835000129(17)260603(10)LL027285
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090017
• 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

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 Expiration Date: 06/03/2026
• Device Catalogue Number: CREFP6
• Device Lot Number: LL027285
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO3 EXTERNAL REFPATCH 6PACK.; CARTO3 EXTERNAL REFPATCH 6PACK.; CARTO3 EXTERNAL REFPATCH 6PACK.
• Patient Sex: Unknown