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	Intraoperative Cardiac Injury (4855)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a premature ventricular contraction (pvc) ablation procedure with navistar catheter, the patient experienced an impaired septal movement.After the procedure was completed using the navistar catheter, ¿the movement of septum has become impaired¿.There was no extended hospitalization required.Causal relationship with product was unknown.There were no error messages observed on hardware/capital equipment.The procedure was completed successfully.Additional information was requested to provide further details about the reported event.However, no information has been provided.
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 31435472m 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).
Additional Manufacturer Narrative
Additional information was received on 28-jul-2025 and the ngen generator details were provided.Therefore, the concomitant product section was updated.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
• 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: 22455520
• Report Number: 2029046-2025-02228
• Device Sequence Number: 12872651
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: (01)10846835000597(17)270902(10)31435472M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 31435472M
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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: NGEN RF GENERATOR, JAPAN.; UNK_NGEN PUMP.; UNK_NGEN PUMP.; UNK_NGEN RF GENERATOR.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Race: Asian