MAUDE Adverse Event Report: BIOSENSE WEBSTER INC 7FR DECAN,11P,F,2.4MMLE,282MM,; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	R7F282CT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Respiratory Failure (2484); Asystole (4442)
Date of Event	12/12/2025
Type of Reportable Event	Death
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 31777545m and no internal action related to the complaint was found during the review.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
It was reported that a patient underwent a cardiac ablation procedure with a decanav catheter and the patient experienced asystole, respiratory arrest, and pulseless electrical activity treated with cpr.The outcome of the event was the patient expired.The report indicated that during electrophysiology (ep) study, the patient went asystole and resulted in death.The ep study was conducted to either rule out or confirm if the patient had ventricular tachycardia (vt), and the patient showed symptoms of respiratory arrest.The patient's heart rate went asystole, a hospital code team was summoned to the procedure room, and cpr was administered, along with emergency intervention.Ablation was not used during the ep study.The devices used during the study were decanav catheter, two quadrapolar catheters, and carto 3 system.Additional information indicated that this adverse event was discovered during use of the products.The physician did say what the cause was, stating only that the patient had some kind of respiratory arrest, followed by a brief period of asystole, followed by pulseless electrical activity (pea).A force-sensing catheter was not used in this procedure.

• Brand Name: 7FR DECAN,11P,F,2.4MMLE,282MM,
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, 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: 24017468
• Report Number: 2029046-2026-00084
• Device Sequence Number: 15691491
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: (01)10846835008807(17)261006(10)31777545M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080425
• 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): 01/08/2026

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: R7F282CT
• Device Lot Number: 31777545M
• 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: 12/12/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• 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: CARTO 3 SYSTEM; NGEN SYSTEM (GENERATOR/PUMP); UNK_C3 WEBSTER QUADRAPOLAR WITH AUTO ID - FIXED; UNK_C3 WEBSTER QUADRAPOLAR WITH AUTO ID - FIXED
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female