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	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a paroxysmal supraventricular tachycardia procedure with a navistar.The patient experienced an av block initially treated with temporary pacemaker.The outcome of the adverse event was unchanged.Conduction recovered to a 2:1 atrioventricular block but did not normalize; a pacemaker was subsequently implanted.The patient required extended hospitalization because of pacemaker implantation.Av block occurred.While waiting after the ablation was completed, since the patient remained in av block, temporary pacemaker was inserted and the patient left the room.No extended hospitalization.The method of cf monitoring was visitag.The coloring settings for visitag was total time.No abnormalities were observed prior/during use of the product.Additional information was received on 11-feb-2026.The information received indicated that the physician¿s opinion on the cause of this adverse event was the procedure.At the onset of junctional rhythm, did not notice it displayed on the recording system.The outcome of the adverse event was unchanged.Conduction recovered to a 2:1 atrioventricular block but did not normalize; a pacemaker was subsequently implanted.The patient required extended hospitalization because of pacemaker implantation.
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 31720912m and no internal actions related to the complaint were 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
In the 3500a initial checked "b2.Is hospitalization initial/prolonged" and "b2.Is required intervention" fields.However, during an internal review on 19-mar-2026, noted a correction to the 3500a initial under h6.Health effect - impact code as it was processed as "recognised device or procedural complication (f15)" in error and should have been processed with "hospitalization or prolonged hospitalization (f08)" and "surgical intervention (f19)".Therefore, updated h6.Health effect - impact code has been 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: 24398002
• Report Number: 2029046-2026-00573
• Device Sequence Number: 9748629
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: (01)10846835000597(17)280806(10)31720912M
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 31720912M
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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: SMARTABLATE GEN. KIT (JAPAN); SMARTABLATE PUMP KIT (JAPAN); UNK RECORDING SYSTEM; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian