MAUDE Adverse Event Report: Biosense Webster Inc VIZIGO; Introducer, Catheter

Catalog Number	D138502
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pericarditis (4448)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure on (b)(6)2026 with a navistar thermocool catheter, varipulse¿ bi-directional catheter, and vizigo sheath, and on the following day the patient experienced pericarditis categorized as moderate and serious defined by hospitalization with an admission date of (b)(6)2026 and a discharge date of (b)(6)2026.Relationship to study devices (varipulse, vizigo and navistar thermocool) is possible and relationship to the index study procedure is possible.The adverse event is anticipated.The outcome is resolved with an end date of (b)(6)2026.Intervention was medication (colchicine).There are three reports for this event for the navistar thermocool catheter, varipulse¿ bi-directional catheter, and vizigo sheath.This report is for the vizigo.
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).

• Brand Name: VIZIGO
• Common Device Name: Introducer, Catheter
• Manufacturer (Section D): Biosense Webster Inc; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): Freudenberg Medical LLC; 2301 centennial blvd; jeffersonville IN 47130
• Manufacturer Contact: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50200213
• Report Number: 3013300026-2026-02550
• Device Sequence Number: 5482330
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: (01)10846835016277(17)280130(10)60000856
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K170997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: D138502
• Device Lot Number: 60000856
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown