MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR THERMOCOOL; 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	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a navistar thermocool catheter and the medical team found intermittent or low irrigation on the device but not complete occlusion.No error messages were noted prior to the issue.The issue was discovered since the temperature abnormally increased, resulting in the inability to discharge.After removing the catheter from the patient's body, the surgeon opened the three-way valve and activated the fast-flushing function of the pump and found that the catheter tip could not release water.The three-way valve can discharge water, so it is determined that there is a problem with the pipeline.The correct settings were selected on the generator.A second device was used to complete the operation.There was no adverse event reported on patient.
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).
Additional Manufacturer Narrative
On 27-nov-2025, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent a cardiac ablation procedure with a navistar thermocool catheter and the medical team found intermittent or low irrigation on the device but not complete occlusion.No error messages were noted prior to the issue.The issue was discovered since the temperature abnormally increased, resulting in the inability to discharge.After removing the catheter from the patient's body, the surgeon opened the three-way valve and activated the fast-flushing function of the pump and found that the catheter tip could not release water.The three-way valve can discharge water, so it is determined that there is a problem with the pipeline.The correct settings were selected on the generator.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection, irrigation test of the returned device were performed in accordance with j&j procedures.Visual analysis of the returned device revealed that there was a big bent in the shaft close to the handle area.The temperature and impedance test was performed and high temperature issue was observed on the screen.Then, an irrigation test was performed, and the catheter failed the test, there were poor flow through the irrigation hole.Afterwards, an aluminum wire was introduced in the luer hub, and the wire got stuck at middle of the shaft.Finally, the catheter handle was dissected, and the irrigation tube was found folded inside the shaft.A manufacturing record evaluation was performed for the finished device number lot 31546949m and no internal action related to the complaint was found during the review.The damage identified on the shaft could be related to the temperature and irrigation issue reported by the customer; therefore, the complaint was confirmed.The potential cause of the folded irrigation tube could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The instruction for use (ifu) contain the following warning and precautions: flush the catheter with heparinized saline prior to insertion into the body.Always follow standard practices of using a continuous drip of anticoagulant fluid under pressure through the proximal luer connector when the device is in the body.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).

• Brand Name: NAVISTAR THERMOCOOL
• 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: 23635923
• Report Number: 2029046-2025-03890
• Device Sequence Number: 18470675
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: (01)10846835000566(17)280130(10)31546949M
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/18/2025

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: 31546949M
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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: STOCKERT PUMP.; UNSPECIFIED GENERATOR.
• Patient Sex: Unknown