MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SF NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	BNI35DFH
Medical Device Problem Codes	Insufficient Cooling (1130); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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 reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool sf nav and an irrigation issue happened mid procedure.After the catheter was advanced into the body, rf (radiofrequency) energy was applied for the first time.The temperature began to rise and exceeded the cut-off value, causing the rf to stop automatically.The catheter connection cables were replaced.During the second rf attempt, the temperature again increased and reached the cut-off value, resulting in another automatic shutdown.When the catheter was removed from the body, the medical team observed that the irrigation fluid did not flow at the preset rate.The intermediate line was disconnected, confirming that the issue was not due to the line.It was then determined that the catheter¿s irrigation system was obstructed, and the catheter was replaced with a new one.The issue was resolved by replacing the catheter.No patient consequences were reported.
Additional Manufacturer Narrative
On 16-dec-2025, the product investigation was completed.It was reported that a patient underwent a cardiac ablation procedure with a thermocool sf nav and an irrigation issue happened mid procedure.After the catheter was advanced into the body, rf (radiofrequency) energy was applied for the first time.The temperature began to rise and exceeded the cut-off value, causing the rf to stop automatically.The catheter connection cables were replaced.During the second rf attempt, the temperature again increased and reached the cut-off value, resulting in another automatic shutdown.When the catheter was removed from the body, the medical team observed that the irrigation fluid did not flow at the preset rate.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection, irrigation, 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 failed the test due to being occluded with dry reddish material inside the dome.A manufacturing record evaluation was performed for the finished device lot number 31436733l and no internal action was found during the review.The high temperature and irrigation issue reported by the customer was confirmed.The potential cause for the occlusion could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.The instructions for use (ifu) contain the following information: flush the catheter and the tubing per standard technique to ensure purging of trapped air bubbles and to verify that the irrigation holes are patent.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 reference number: (b)(4).
Additional Manufacturer Narrative
On 21-nov-2025, bwi received additional information regarding the event.No error was detected in the irrigation pump.The problem was detected when the catheter reached the cut-off temperature and automatically stopped ablation when ablation was initiated.The correct catheter settings were selected.No problems with the flow rate were initially encountered.The catheter was thoroughly rinsed before being inserted into the body, ensuring its fluidity was maintained.On 12-dec-2025, the bwi product analysis lab received the device for evaluation.The 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 reference number: (b)(4).

• Brand Name: THERMOCOOL SF NAV
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 23500635
• Report Number: 2029046-2025-03750
• Device Sequence Number: 8965826
• Product Code: LPB
• UDI-Device Identifier: 10846835003215
• UDI-Public: (01)10846835003215(17)31436733L(10)31600163L
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P030031/S025
• 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,Followup
• Report Date (Section B): 01/12/2026

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: BNI35DFH
• Device Lot Number: 31436733L
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 12/16/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/16/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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