MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NI75TCFH
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	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and the device was not flushing correctly.The issue was noted after the medical team had started the first ablation.Some of the irrigation holes felt like they were plugged.They removed the catheter from the patient's body and noted that three of the irrigation holes were clogged and not flushing probably.The correct catheter settings were selected on the generator.The pump was also set correctly as well.However, the temperature rose as soon as ablation started.The catheter was replaced.No further details were provided regarding completion of the procedure.No patient consequences were reported.
Additional Manufacturer Narrative
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.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).
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and the device was not flushing correctly as some of the irrigation holes felt like they were plugged after use on patient.In addition, there was a temperature issue.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection, temperature and impedance, and irrigation tests of the returned device were performed in accordance with j&j medtech procedures.Visual analysis of the returned device revealed that no damage or anomalies were observed on the device.Temperature and impedance test 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 irrigation and high temperature issues reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations: when rf current is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned of coagulum if present.As part of the 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.No: (b)(4).

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21551359
• Report Number: 2029046-2025-00721
• Device Sequence Number: 11867158
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: (01)
• 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): 03/07/2025

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: NI75TCFH
• Device Lot Number: 31521343M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DEF 7.5F,TCNSTC,4P,F,252MM,HYP.; UNKNOWN GENERATOR.; UNK_SMARTABLATE PUMP.
• Patient Sex: Unknown