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

Catalog Number	D128208
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and dimensional test were performed following j&j medtech procedures.Visual analysis revealed that one of the splines was detached, with exposed wires, missing electrodes and stress marks.Evidence of good manufacturing of the device was observed.The dimensional test was performed, and the measures were within specifications.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The customer complaint was confirmed as the damage observed on the spines and electrodes could be related to the reported event.The potential cause of the separation of the spline and electrode could be related to the manipulation of the device during the procedure.The stress marks observed suggest that excessive force was applied to the device.A user error was identified as the patient had a mechanical mitral valve and the instructions for use (ifu) of the device state that do not use the catheter in patients with prosthetic valves.In addition, the ifu includes the following recommendation: do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.As part of johnson & johnson medtech¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 a cardiac ablation procedure with a pentaray nav and the catheter splines got stuck in the mechanical mitral valve.Splines are not working and they changed the catheter.There was no patient consequence.This event was originally assessed as not mdr reportable.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and dimensional test were performed.Visual analysis revealed that one of the splines was detached, with exposed wires, missing electrodes and stress marks.This finding is mdr reportable.

• 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: 23653647
• Report Number: 2029046-2025-03926
• Device Sequence Number: 15926990
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: (01)10846835012224(17)271217(10)31530131L
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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 Catalogue Number: D128208
• Device Lot Number: 31530131L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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