MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAV; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	BN7TCDF4L
Medical Device Problem Codes	Signal Artifact/Noise (1036); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with an ez steer nav and the plastic had melted.It was reported that the ez steer nav had noise on distal on the carto 3 system.The cable was replaced without resolution.The catheter was replaced, and the problem was resolved.The caller added that when they removed the catheter, they found a deformation on the catheter, and it looked like the plastic had melted.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with an ez steer nav and the plastic had melted.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and electrical test of the returned device were performed.Visual inspection revealed that the tip was torn and bent with internal parts exposed.No other issues or anomalies were observed.Electrical testing showed no faults.A manufacturing investigation was initiated because of the tip damage.The investigation concluded that a manufacturing-related cause could not be confirmed, as there was no evidence that the tip was damaged during the manufacturing process.Review of the device history records (dhr) showed the unit passed all process controls, including the temperature and continuity tests.Additionally, no other catheters from the same batch have been reported with a similar issue.A manufacturing record evaluation for the finished-device batch identified no internal actions.The tip damage found could be related to the noise and melted tip conditions reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The instructions for use (ifu) contain the following recommendations: the electrocardiogram (ecg) noise is typically generated as the result of the improper connection of the body surface electrocardiogram (ecg) patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.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.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
On 20-jan-2026, additional information was received indicating the catheter defamation was seen on the tip.Device looked deformed and was assumed to have melted near the tip but there was no high temperature error or report found.On 22-jan-2026, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

• Brand Name: EZ STEER NAV
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 24039362
• Report Number: 2029046-2026-00108
• Device Sequence Number: 10482137
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: (01)10846835002997(17)280924(10)31768561M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S12
• 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,Followup

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: BN7TCDF4L
• Device Lot Number: 31768561M
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 03/03/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/18/2026; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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: NGEN RF GENERATOR.
• Patient Sex: Unknown