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	Vasospasm (2128)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
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 31083535m 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).
Event or Problem Description
During cardiac ablation procedure with navistar catheter, the patient experienced coronary vasospasm treated with percutaneous balloon inflation and intra-aortic balloon pump (iabp) placed, which required prolonged hospitalization.It was reported that during aortic coronary cusp ablation with navistar catheter, contrast examination was performed because the patient complained of chest pain.Coronary vasospasm was observed in a segment of the left coronary artery, and percutaneous balloon inflation was performed.The ablation was stopped at that point.After the procedure, the patient's symptoms were improving; however, an iabp was placed, and the patient was sent to the intensive care unit (icu).The physician¿s assessment of the health hazard was non-serious (moderate/minor).Extended hospitalization was noted.The coloring settings for visitag was tag index.The visitag additional filters used was impedance drop.The relationship with the product was causal.There were no abnormalities observed prior to or during use of the product.Additional information received indicated that the outcome of the adverse event was improved.
Additional Manufacturer Narrative
On 29-dec-2025, additional information was received indicating the physician¿s opinion on the cause of the adverse event was that it was procedure related.No relevant tests/laboratory data or other relevant history/preexisting condition were noted.A smartabalate generator and smartablate pupm were used for the procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 23824323
• Report Number: 2029046-2025-04178
• Device Sequence Number: 20100664
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: (01)10846835000597(17)260615(10)31083535M
• 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): 12/16/2025

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 Expiration Date: 06/15/2026
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 31083535M
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2023
• 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_CARTO 3
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian