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

Catalog Number	CREFP6
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation 04-apr-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.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
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 opened the box, the sterile packaging was already unsealed.New reference patch was opened and used.Issue occurred pre-op.The procedure was completed without any problems.No patient consequence.Additional information received confirmed the device was not used on the patient.The packaging not available since the packaging was discarded.
Additional Manufacturer Narrative
Additional information was received on 01-may-2025 provided an additional concomitant product of carto3 external refpatch 6pack / crefp6.Therefore, updated section ¿d10.Concomitant medical products and therapy dates.¿ additional information was received on 07-may-2025 which clarified that only one of the carto3 external refpatch 6pack / crefp6 had the reported issue of, "when opened the box, the sterile packaging was already unsealed." the device evaluation was completed on 08-may-2025.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a reference patch carto 3.When opened the box, the sterile packaging was already unsealed.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and a supplier manufacturing investigation were performed.Visual inspection revealed that the packaging was not sealed from one of the edges.No other anomalies were observed.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 not an specific control established for sealing inspection.A device history record evaluation was performed for the finished device number, and no internal action related to the reported condition were identified.The pouch seal issue reported by the customer was confirmed.The root cause is the manufacturing process.An awareness session was performed to avoid this issue.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.An internal corrective action has been opened to mitigate pouch seal issues.Explanation of codes: investigation findings: manufacturing process problem identified (c16)/ investigation conclusions: cause traced to manufacturing (d03) / component code: packaging (g04094) were selected as related to the customer¿s reported, ¿when opened the box, the sterile packaging was already unsealed¿ issue.In addition, biosense webster inc.Analysis finding of the ¿manufacturing process¿ related.-investigation findings: packaging problem identified (c1605) / investigation conclusions: cause traced to manufacturing (d03) / component code: packaging (g04094) were selected as related to the customer¿s reported, ¿when opened the box, the sterile packaging was already unsealed¿ issue.In addition, biosense webster inc.Analysis finding of the ¿packaging was not sealed from one of the edges¿.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: 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: 21715687
• Report Number: 2029046-2025-00944
• Device Sequence Number: 4539436
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/04/2025; 05/01/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/08/2025; 05/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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; OCTA,LNG,48P,3-3-3-3-3,D-CURVE; UNK CABLE
• Patient Sex: Unknown