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 Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with two navistar® rmt thermocool® electrophysiology catheter¿s and irrigation issues during use on the patient occurred.The navistar® rmt thermocool® electrophysiology catheter was only flushing out of 4 of its 6 irrigation ports.It was discovered after attempting radio frequency (rf) delivery and a pump error appeared (code unknown) after 10 seconds of ablation.The catheter was removed and the irrigation issue was noticed.It was confirmed it was irrigating during rf delivery.The catheter was exchanged (with one from the same lot) and the same issue occurred.They replaced the catheter again.This time from a different lot and there were no issues.The procedure continued successfully.There was no patient consequence reported.Additional information was received.The suspected device for the reported flow/irrigation issue was the catheters.The smartablate pump was used.The steps taken to resolve the irrigation issue was swapping catheter, then swapping pump.The correct catheter settings were selected on the generator.Pump was switching from ¿low¿ to ¿high¿ flow during ablation.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-01437 for product code nr7tcsiy (navistar rmt thermocool); (2) mfr # 2029046-2024-01438 for product code nr7tcsiy (navistar rmt thermocool).
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 15-may-2024.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a navistar® rmt thermocool® electrophysiology catheter¿s and irrigation issues during use on the patient occurred.The device evaluation was completed on 31-may-2024.The device was returned to biosense webster for evaluation.A visual inspection, and irrigation test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device was connected to the pump and an irrigation test was performed, and the device irrigated correctly.No pump error was observed.The device was flushing correctly and no obstructed holes were observed.No malfunctions were observed during the device analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The irrigation issue 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 warning and precautions: purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.Inspect the irrigation saline for air bubbles prior to its use in the procedure.Air bubbles in the irrigation saline may cause emboli.Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.As part of biosense webster'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: 19230966
• Report Number: 2029046-2024-01437
• Device Sequence Number: 12445726
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/26/2024

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: 04/20/2026
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 31039182M
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 05/15/2024; 05/31/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/20/2024; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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: NAVISTAR RMT THERMOCOOL.; UNKNOWN GENERATOR.; UNK_SMARTABLATE PUMP.
• Patient Sex: Unknown