MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER THERMOCOOL NAV; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BNI75TCDFH
Medical Device Problem Codes	Insufficient Cooling (1130); Obstruction of Flow (2423); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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 an ez steer thermocool nav catheter and the smartablate pump kit-ww.The catheter had blocked channels (device used in patient).Temperature and impedance not acting as expected.It seemed like the catheter had blocked channels.Took some pictures from ablation.No patient consequence.Additional information was received on 17-dec-2025.The temperature value was displayed high.The system stopped the ablation when the cut off value exceeded.The smartablate generator was used with default thermocool settings.The impedance value displayed at both high and low.The system stopped accordingly.Confirmation received indicated that the ¿blocked channels¿ referred to an irrigation issue.The suspected device for the flow / irrigation issue was thought to be the pump malfunctioning.The ez steer thermocool nav catheter was used in the patient.No errors, just problems with temperature and impedance.New pump was used.The smartablate generator kit-ww and smartablate pump kit-ww were used.
Additional Manufacturer Narrative
The device evaluation details.It was reported that a patient underwent a cardiac ablation procedure with an ez steer thermocool nav catheter and the smartablate pump kit-ww.Temperature and impedance not acting as expected.It seemed like the catheter had blocked channels.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation 06-jan-2026.Following j&j medtech procedures, a visual inspection, irrigation and temperature and impedance test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.The device was connected to the generator and an ablation cycle was performed and the device was found working correctly.No temperature or impedance issues were observed.An irrigation test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The high temperature, impedance and irregular irrigation 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 carto® 3 system instructions for use (ifu) contain the following information: do not use a navistar catheter with the thermistor temperature sensor for ablation.The rf generator does not display the temperature for these catheters.Use a navistar catheter with the thermocouple temperature sensor instead.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.Additional information was received on 08-jan-2026 which indicated that the catheter was replaced as part of the troubleshooting.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: EZ STEER THERMOCOOL NAV
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 23882887
• Report Number: 2029046-2025-04285
• Device Sequence Number: 15865759
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: (01)10846835003338(17)280904(10)31744178M
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P030031
• 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
• Report Date (Section B): 01/29/2026

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: BNI75TCDFH
• Device Lot Number: 31744178M
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• 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: SMARTABLATE GENERATOR KIT-WW.; SMARTABLATE PUMP KIT-WW.
• Patient Sex: Unknown