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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a wolff-parkinson-white (wpw) and mid-septal accessory pathway ablation procedure with a navistar thermocool, the patient had 45 minutes of third-degree atrioventricular (av) block.The patient received only one ablation.Ablation duration 7 seconds at 40 watts, high flow 17 ml/min with a maximum temperature of about 37°c.Electrogram signals showed av block in one heartbeat, after that the ablation was stopped.The qrs complex was wider than before ablation and conduction to the ventricle was via accessory pathway.The patient had 45 minutes of third-degree av block.Av conduction returned after a waiting period.Before starting the ablation, the catheter caused a block in the accessory pathway and at the same time there was no visible his bundle signal on the mapping 1-2 or 3-4 channels.The distance to the his catheter was also checked with fluoroscopy.Therefore, it was thought that it was safe to start the ablation.No surgery delay reported due to the event.The patient¿s consequence was temporary av block.No medical intervention noted.There was no problem with the catheter.The physician¿s opinion on the cause of this adverse event was that the ablation was delivered too close to conduction system.The patient fully recovered (no residual effects).The patient did not require extended hospitalization.The energy source used when the adverse event occurred was radiofrequency.The procedural activated clotting time was not measured.No catheter exchanges occurred during the procedure or transseptal punctures.No ablations were performed within/outside the pulmonary veins.
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31617042m and no internal actions related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.However, if the product is received at a later date, the investigation will be updated as applicable.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.No: (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: 23017610
• Report Number: 2029046-2025-03078
• Device Sequence Number: 9664883
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: (01)10846835000559(17)280327(10)31617042M
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 31617042M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 46 KG