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

Catalog Number	NI75TCDH
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	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a navistar thermocool catheter and the irrigation issue was not noted before the device was used on patient.Occlusion/ no irrigation.During the procedure, device (including port, luer hub) was not irrigating.A second device was used to complete the procedure.There was no adverse event reported on patient.Additional information was received on 10-dec-2024.The suspected device for the reported flow/irrigation issue is the catheter.The issue was not noted before the device was used on the patient.No error, during the procedure, there was a high temperature reading.Withdrawing the catheter, found there was an intermittent or low irrigation on the device.They manually pressurized drainage to increase flow rate to resolve the issue.The correct catheter settings were selected on the generator.No issues with the flow rate change at the start of ablation.Additional information was received on 18-dec-2024.The temperature cut off value was exceeded.However, the system stopped the ablation when the cut-off value was exceeded.The generator was set to power control mode, 48, 40w, 25ml/s.The noted temperature during issue was 49.This event was originally considered non-reportable, however, bwi became aware on 10-dec-2024 that the irrigation issue was not noted before the device was used on the patient and have reassessed the event as reportable.The awareness date for this record is 10-dec-2024.
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
It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a navistar thermocool catheter.During the procedure, device (including port, luer hub) was not irrigating.A second device was used to complete the procedure.There was no adverse event reported on patient.Additional information was received.The suspected device for the reported flow/irrigation issue is the catheter.The issue was not noted before the device was used on the patient.No error, during the procedure, there was a high temperature reading.He temperature cut off value was exceeded.However, the system stopped the ablation when the cut-off value was exceeded.Withdrawing the catheter, found there was an intermittent or low irrigation on the device.They manually pressurized drainage to increase flow rate to resolve the issue.The device was returned to johnson and johnson medtech (j&j) for evaluation on 13-jan-2025.Visual inspection, temperature, impedance, and irrigation tests of the returned device were performed following j&j procedures.Visual analysis revealed no damage or anomalies on the device.The 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, the flow in the irrigation hole was very poor.Afterwards, an aluminum wire was introduced in the luer hub, and the wire got stuck at the tip area.Finally, tip was dissected, and the irrigation tube was inspected, and it was found the irrigation tube found folded at the tip section.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The temperature failure could be caused by the occlusion identified during the analysis; therefore, the complaint was confirmed.The potential cause of the folded irrigation tubing cannot be determined.The instruction for use (ifu) contain the following warning and precautions: load the irrigation tubing set in the pump.Open the stopcock and flush the tubing per the instructions for use for the pump until the air is expelled through the open end of the tubing.Flush the catheter and the tubing to ensure purging of trapped air bubbles and to verify that the irrigation holes are patent.If irrigation hole occlusion occurs: fill a 1- or 2-ml syringe with sterile saline and attach it to the stopcock on the end of the irrigation tubing or the sidearm on the catheter.Carefully inject the saline from the syringe into the catheter.A stream of fluid should be visible from all six holes.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21068081
• Report Number: 2029046-2025-00025
• Device Sequence Number: 8399368
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: (01)10846835000559(17)270927(10)31456405M
• 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): 02/05/2025

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: NI75TCDH
• Device Lot Number: 31456405M
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2024
• 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: SMARTABLATE GENERATOR KIT (CN)
• Patient Sex: Unknown