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

Catalog Number	BNI75TCDFH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a catheter ablation of the slow pathway (casp) procedure with an ez steer thermocool nav catheter, the patient experienced a cardiac block treated with insertion of temporary pacemaker.During the procedure for pvc from the left leg, during ablation from catheter ablation of the slow pathway (casp), bradycardia and cardiac block occurred when the decanav catheter shifted below the valve.A temporary pacemaker was inserted, and the patient was under follow-up observation.The physician assessment of the health problem was serious.No prolongation of hospital stay was noted.The contact force (cf) monitoring method was visitag.The coloring setting of visitag was tag index.The physician's opinion on the relationship between the event and the product was no causal relationship.No abnormalities observed prior/during use of the product.Additional information was received.The physician¿s opinion on the cause of this adverse event was not related to the products.
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 31675034m 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.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 reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on 04-nov-2025.The outcome of the adverse event was unchanged.Since the junctional rhythm remained, permanent pacemaker will be implanted for left bundle branch block (lbbb).The patient has been discharged from the hospital temporarily.No relevant tests/laboratory data noted.Other relevant history/preexisting condition consisted of chronic kidney disease, diabetes mellitus, pulmonary ¿carcinoid¿, and heart failure.Also provided the patient¿s weight and the patient¿s medical history.Therefore, updated a.Patient information and b.Adverse event or product problem sections.In addition, provided the generator and pump information.Therefore, updated section d10.Concomitant medical products and therapy dates.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: EZ STEER THERMOCOOL NAV
• 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: 23317942
• Report Number: 2029046-2025-03456
• Device Sequence Number: 20290497
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: (01)10846835003338(17)280704(10)31675034M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/02/2025

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: BNI75TCDFH
• Device Lot Number: 31675034M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7FR DECAN,11P,F,2.4MMLE,282MM,; NGEN PUMP, JAPAN CONFIGURATION.; NGEN RF GENERATOR, JAPAN,; SMARTABLATE IRR TUBE SET,; UNK_CARTO 3,; UNK_NGEN PUMP,; UNK_NGEN RF GENERATOR,
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian