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

Catalog Number	D138504
Medical Device Problem Codes	Positioning Problem (3009); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a varipulse¿ bi-directional catheter and the patient experienced a cardiac perforation with required surgical intervention.Approximately 20 minutes after initiation of pulmonary vein isolation and after approximately 20 ablations had been performed, the patient's blood pressure suddenly decreased, and pericardial effusion was confirmed by echocardiography.Thoracotomy was performed, and blood transfusion was administered.The patient's blood pressure returned to normal with extracorporeal membrane oxygenation (ecmo).A perforation was located at the tip of the left atrial appendage.The patient required extended hospitalization.The patient¿s condition has improved.Transseptal puncture was performed with scooper rf needle 89 cm (rfn-89dnx).Physician's assessment of health hazard is serious.Physician's comment regarding relationship between the event and the product is that there was an occasion when the vizigo lost deflection.At that time, it was suspected that the varipulse catheter may have been caught on something inside the cardiac chamber.While the vizigo sheath was in a straight configuration within the heart, an attempt was made to apply deflection; however, the sheath could not be deflected.There were no abnormalities observed prior to or during varipulse catheter use.
Additional Manufacturer Narrative
H 6.Medical device problem code of positioning problem (a1502) to reflect the deflection issue is not mdr reportable.An analysis of the product could not be performed since a physical sample was not received for evaluation.A device history record review was performed for the finished device 16997068 number, 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.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: CARTO 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: 50900049
• Report Number: 3013300026-2026-03165
• Device Sequence Number: 5829679
• Product Code: DYB
• UDI-Device Identifier: 10846835026252
• UDI-Public: (01)10846835026252(17)271127(10)16997068
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: D138504
• Device Lot Number: 16997068
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 90 LB
• Patient Race: Asian