MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR; CATHETER, ELECTRODE RECORDING

Catalog Number	NS7TCDL174HS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The report indicated that during an ablation procedure with a navistar catheter, the patient experienced heart block treated with a permanent pacemaker.It was reported that the patient had a complete heart block.During ablation, and really far from the his, two dropped/non-conducting atrial beats were noticed.The physician came off ablation and ventricular paced the patient for conduction.The procedure was aborted.The injury was confirmed by visualizing the signals displayed on the carto 3 system.A permanent pacemaker was placed in the patient.The last known patient status was reported as stable.Generator used for ablation was a ngen.Additional information was received which indicated that the physician¿s opinion on the cause of this adverse event was anatomy related.The patient required overnight hospitalization.
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 lot number 31629072m and no internal action 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.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).

• Brand Name: NAVISTAR
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: 22524623
• Report Number: 2029046-2025-02354
• Device Sequence Number: 8632938
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: (01)10846835000597(17)280413(10)31629072M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990025
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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: NS7TCDL174HS
• Device Lot Number: 31629072M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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: CARTO 3 SYSTEM; NGEN GENERATOR
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic