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

Catalog Number	D128208
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav catheter for which biosense webster¿s product analysis lab (pal) identified the tip section separated from the shaft on the device.Catheter curvature error.No patient consequence.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2026 the tip section separated from the shaft on the device.The event was originally considered non-reportable, however, bwi became aware that the tip section separated from the shaft on the device on the device on 31-jan-2026 and have assessed this returned condition as reportable.
Additional Manufacturer Narrative
The device evaluation details.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 12-jan-2026.Following j&j medtech procedures, a visual inspection and deflection test of the returned device were performed.Visual inspection revealed the tip section separated from the shaft on the device.A deflection test was performed and the device was deflecting within specifications.No deflection issues were observed.A manufacturing investigation was requested to define the root cause of the separation of the tip area.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the use of the device that may have affected its performance.The tip separation is unrelated to the issue originally reported.The root cause of the separation of the tip with the shaft was the incorrect assembly of the polyimide into the tip.The instructions for use (ifu) contain the following information: do not immerse the handle or the cable connector in fluids; electrical performance could be affected.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿catheter curvature error¿ issue.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause traced to manufacturing (d03) / component code: tip (g04129) were selected as related to the biosense webster inc.Analysis finding of the ¿tip section separated from the shaft on the device¿.-investigation findings: manufacturing process problem identified (c16)/ investigation conclusions: cause traced to manufacturing (d03)/ component code: tip (g04129) were selected as related to the biosense webster inc.Analysis finding of the ¿the incorrect assembly of the polyimide into the tip¿.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).

• 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: 24430814
• Report Number: 2029046-2026-00629
• Device Sequence Number: 16026775
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: (01)10846835012224(17)280715(10)31714455L
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: D128208
• Device Lot Number: 31714455L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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
• Patient Sex: Unknown