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

Catalog Number	NI75TCDH
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
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 a cardiac ablation procedure with a navistar thermocool and it was not irrigating during use on the patient.It was initially reported by the customer that during the operation, device (including port, luer hub) was not irrigating.A second device was used to complete the operation.There was no adverse event reported on patient.The customer's reported occlusion issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 25-aug-2025, additional information was received indicating the navistar thermocool was used on the patient and there were no errors given by the irrigation pump.The device was re-entered into the patient's body, they found no irrigation.To troubleshoot they tried high flow irrigation and wiped the catheter tip.The correct catheter settings were selected on the generator and there were no issues with flow rate change at the start of ablation.Based on the additional information received which indicated the event occurred while the device was in the patient¿s body, the event has been reassessed as an mdr reportable malfunction.
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a navistar thermocool and it was not irrigating during use on the patient.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation on 25-sep-2025.Visual inspection and irrigation test of the returned device were performed following j&j procedures.Visual analysis revealed no damage or anomalies on the device.An irrigation test was performed, and the catheter failed the test; no flow was observed in the irrigation hole.Afterwards, an aluminum wire was introduced in the luer hub and the wire got stuck in different section of the shaft.Finally, the irrigation tube was dissected and observed on the microscope and it was found occluded with dry reddish material.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The irrigation issue reported by the customer was confirmed.The potential cause of the occlusion cannot be 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 ref.(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: 23002118
• Report Number: 2029046-2025-03050
• Device Sequence Number: 9518982
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: (01)10846835000559(17)271119(10)31508562M
• 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

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: NI75TCDH
• Device Lot Number: 31508562M
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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: UNKNOWN GENERATOR; UNKNOWN IRRIGATION PUMP
• Patient Sex: Unknown