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

Catalog Number	NR7TCSIY
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	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an idvt (idiopathic deep vein thrombosis) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and there was an irrigation issue.The carto 3 system was displaying a high temperature readings during ablation.The cable was replaced without resolution.The catheter was removed from the body and they noticed that parts of the tip of the catheter was not irrigating properly.The catheter was replaced and the issue was resolved.Procedure was continued.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
On 30-sep-2024, the product investigation was completed.It was reported that a patient underwent an idvt (idiopathic deep vein thrombosis) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and there was an irrigation issue.The carto 3 system was displaying a high temperature readings during ablation.The cable was replaced without resolution.The catheter was removed from the body and they noticed that parts of the tip of the catheter was not irrigating properly.The catheter was replaced and the issue was resolved.Procedure was continued.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.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 number lot 31067835m and no internal action related to the complaint was found during the review.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® RMT THERMOCOOL® 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: 20182555
• Report Number: 2029046-2024-03011
• Device Sequence Number: 20898194
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: (01)10846835008500(17)260601(10)31067835M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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 Expiration Date: 06/01/2026
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 31067835M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• 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: CARTO 3 SYSTEM; SMARTABLATE GENERATOR
• Patient Sex: Unknown