MAUDE Adverse Event Report: BIOSENSE WEBSTER INC REFERENCE PATCH CARTO 3; 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	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 27-mar-2025.The analysis has begun but is not 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 reference patch carto 3.When they opened the packaging for the patches, each of the patches were not sealed.Advised the caller to not use the patch set.No patient consequence reported.Additional information was received.They did not take any photos of the open packaging.The packaging was sent back by the customer.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a reference patch carto 3.When they opened the packaging for the patches, each of the patches were not sealed.Advised the caller to not use the patch set.No patient consequence reported.The device evaluation was completed on 14-apr-2025.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection of the returned devices was performed following j&j medtech procedures.Visual analysis revealed that one side of the packages was not sealed.Per the condition observed, a manufacturing investigation was performed.It was concluded that the issue was caused by human error/gap in the process as there was no specific control established for sealing inspections.An internal corrective action has been opened to mitigate pouch seal issues.A device history record was performed for the finished device batch number, and no internal actions were identified.The open pouch seal issue reported by the customer was confirmed.The instruction for use (ifu) of the device contain the following recommendation: 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

• Brand Name: REFERENCE PATCH 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): LEAD-LOK INC; 814 airport way; sandpoint ID
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21721810
• Report Number: 2029046-2025-00952
• Device Sequence Number: 13134668
• Product Code: DQK
• UDI-Device Identifier: 20846835000129
• UDI-Public: (01)20846835000129(17)260504(10)LL027173
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: 05/04/2026
• Device Catalogue Number: CREFP6
• Device Lot Number: LL027173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown