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

Catalog Number	NR7TCSIY
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 rmt thermocool catheter, and the patient experienced cardiac tamponade treated with drainage.It was reported that during the procedure, three hours after the start of the procedure, cardiac tamponade occurred.The procedure was completed with drainage performed, and the procedure was terminated.No extended hospitalization was noted.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.The energy source used when the adverse event occurred was radiofrequency (rf).One catheter was used during the procedure.One transseptal puncture site was performed during the procedure.The energy delivered for each group of performed ablations was radiofrequency (rf).The outcome of the adverse event was fully recovered (no residual effects).The patient was discharged from the hospital on (b)(6) 2025.The patient did not require extended hospitalization.No relevant tests/laboratory data or other relevant history/pre-existing condition was noted.The procedural activated clotting time (act) was 329 seconds.The number of performed ablations was 9 ablations outside the pulmonary veins.No ablations were performed within the pulmonary veins.
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 31469901m 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: NAVISTAR RMT THERMOCOOL
• 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: 23612899
• Report Number: 2029046-2025-03874
• Device Sequence Number: 13280039
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: (01)10846835008500(17)271015(10)31469901M
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: NR7TCSIY
• Device Lot Number: 31469901M
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 11/22/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• 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: SMARTABLATE PUMP KIT (JAPAN); SMARTABLATE REMOTE KIT (JAPAN); UNK_SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian