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

Catalog Number	CREFP6
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a reference patch carto 3 and when the medical team opened the outer box, the inner bag was not sealed with adhesive and was left open.The reference patch was used on the patient based on the physician's decision, as it is not a sterile product.The procedure was completed without patient consequence.
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 reference number: (b)(4).
Additional Manufacturer Narrative
The manufacture date has been provided as 03-dec-2024.Therefore, h 4.Device manufacture date has been updated.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
Hardware evaluation was completed on 11-aug-2025.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a reference patch carto 3 and when the medical team opened the outer box, the inner bag was not sealed with adhesive and was left open.The package without the product was returned to johnson & johnson medtech (j&j medtech) for investigation; however, the package was mistakenly discarded.Therefore, it was not available for investigation.A supplier manufacturing investigation was carried out on lot ll027179, and it was concluded that the issue was caused by human error/gap in the process, as there was not a specific control established for sealing inspection.This could be related to the event reported on this complaint.A device history record evaluation was performed for the finished device number ll027179, and no internal actions related to the reported condition were identified.The pouch issue reported was confirmed, as the lot number reported was identified with the defect described by customer (open/unsealed pouches).The root cause of the package issue is the manufacturing process.The instructions for use (ifu) contain the following information: inspect the external reference patch to ensure that it is in good physical condition.Care should be taken when opening the packaging to ensure that the sealing mechanism is not damaged.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.Supplier actions are being performed to mitigate pouch seal issues (retraining, added a pouch seal inspection in the process).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: 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: 22294753
• Report Number: 2029046-2025-02022
• Device Sequence Number: 12839693
• Product Code: DQK
• UDI-Device Identifier: 20846835000129
• UDI-Public: (01)20846835000129(17)260422(10)LL027179
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2025

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 Expiration Date: 04/22/2026
• Device Catalogue Number: CREFP6
• Device Lot Number: LL027179
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 08/11/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/28/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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
• Patient Sex: Unknown