MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO; INTRODUCER, CATHETER

Catalog Number	D138504
Medical Device Problem Codes	Material Separation (1562); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 (b)(6) 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.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).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure and the patient experienced air embolism that required aspiration with a pigtail catheter.After performing pre-mapping of left atrium, vizigo priming was performed and air was confirmed to have been aspirated into the syringe.No specific error was observed.The hemostatic valve dislodged inside the hub.The hemostatic valve itself was not broken/cracked.Fluoroscopy confirmed the presence of air in the right atrium which was subsequently aspirated using a pigtail catheter.Coronary angiography was also performed.At the time of leaving the procedure room, the hemodynamic status was unchanged from baseline, and no cerebral infarction or other complications were observed the following day.Patient was asymptomatic.Magnetic resonance imaging was performed but no cerebrovascular accident occurred.There was no evidence of char nor blood thrombus/clot.The physician's opinion on the cause of the adverse event was that the tip of the vizigo was in contact with the myocardium, and it is possible that negative pressure was generated during air purging, resulting in air being aspirated.Damage to the hemostatic valve also cannot be ruled out.As the patient was breathing heavily, the possibility that the issue was patient-related cannot be excluded.

• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 25860936
• Report Number: 3013300026-2026-02338
• Device Sequence Number: 5193635
• Product Code: DYB
• UDI-Device Identifier: 10846835026252
• UDI-Public: (01)10846835026252(17)280311(10)17718499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D138504
• Device Lot Number: 17718499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2026
• 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; Life Threatening
• Patient Sex: Male
• Patient Race: Asian