MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710FJ282CT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a persistent atrial fibrillation (paf) ablation while using a webster cs (coronary sinus) catheter, the patient experienced pericardial effusion treated confirmed with ice (intracardiac echocardiography) catheter and treated with pericardiocentesis and removal of 19ml of fluid.Prior to gaining transseptal access, the patient's blood pressure began to decrease.The patient required extended hospitalization because the patient was kept for a couple of days for monitoring the effusion, and a tee (transesophageal echocardiogram) being performed.The outcome of the adverse event fully recovered (no residual effects).The webster cs catheter is not available for return.Farapulse system was planned for use, but no pfa (pulse field ablation) ablation was performed.The following bwi devices were also in use soundstar catheter (not available for return), carto 3 system.The webster cs catheter and the soundstar catheter were both brand new.The information received indicated that this adverse event was discovered after the webster was used on the patient.The physician was unsure of what caused the event.No transseptal puncture was performed, but versacross connect laac access solution was in the patient's body.The patient did not require cardiac surgery.
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 31788226m 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.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).

• Brand Name: WEBSTER
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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: 24191085
• Report Number: 2029046-2026-00318
• Device Sequence Number: 9513912
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: (01)10846835002423(17)281021(10)31788226M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• 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
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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: BD710FJ282CT
• Device Lot Number: 31788226M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2025
• 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; SOUNDSTAR ECO GE 10F CATHETER; UNK_NGEN RF GENERATOR
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 82 KG