MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D128207
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A picture was received for evaluation following johnson & johnson medtech (j&j medtech) procedures.According to the picture provided by the customer, the lot number printed on the label of pouch does not match with the lot number printed on the outer box.The root cause of the mismatch labeling is related to the copacker process.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.An internal corrective action was created to investigate the copacker issues.H6.Investigation findings code of "appropriate term/code not available (c22)" represents photo/video analysis.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 two units have been noted to have incorrect labels.The inner pouch label shows a different product code than the outer box label.No adverse patient consequence was reported.

• Brand Name: PENTARAY NAV
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24203114
• Report Number: 2029046-2026-00346
• Device Sequence Number: 15871105
• Product Code: MTD
• UDI-Device Identifier: 10846835012217
• UDI-Public: (01)10846835012217(17)280917(10)31765412L
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K123837
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: D128207
• Device Lot Number: 31765412L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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: PENTARAY NAV ECO 7FR, F, 4-4-4.
• Patient Sex: Unknown