MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number	F6QA005RT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Date of Event	11/19/2025
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 a webster quad catheter, the patient experienced ventricular fibrillation (vf) treated with chest compressions and defibrillation about 5-6 times.The last known status of the patient was that their blood pressure was normal, they were in sinus rhythm, and a stat echo was ordered.It was reported that while stemming the ventricle to see the severity of the patient's vt (ventricular tachycardia), it started in vt and deteriorated into vf.The patient¿s blood pressure plummeted, and the medical team had to call a code.The patient was already intubated when they noticed the drop in blood pressure.They noticed this due to the 12lead being all vf and was confirmed on x-ray and with the quad catheter that was in the right ventricle.The only known medical intervention provided to the patient were chest compressions and defibrillation about 5-6 times.The only bwi in use at the time was a quad catheter (fix 6f,4p,a,sd,5mm,10pn-dr,115), carto 3 system, and patches on the patient.No generator was in use, and the case was aborted.The information received indicated that the intervention provided was anesthesia protocol.The outcome of the adverse event was improved.The patient was under general anesthesia with time unknown.No transseptal puncture was performed prior to the case cancellation.
Additional Manufacturer Narrative
On 21-jan-2026, the product investigation was completed as the complaint device was not returned.Device investigation details: 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 31733851m 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 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: WEBSTER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• 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: 23796296
• Report Number: 2029046-2025-04127
• Device Sequence Number: 10470748
• Product Code: LDF
• UDI-Device Identifier: 10846835000481
• UDI-Public: (01)10846835000481(17)280813(10)31733851M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K892265
• 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,Followup
• 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: F6QA005RT
• Device Lot Number: 31733851M
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Male