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

Catalog Number	D138503
Medical Device Problem Codes	Fluid/Blood Leak (1250); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a vizigo sheath and observed the valve on the back leaking and blood backflow.After the vizigo sheath went transseptal, the valve on the back was leaking and there was a blood backflow.The sheath was replaced and the issue resolved.The procedure continued with no further issues.No patient consequence reported.Additional information was received.Unsure if the hemostatic valve dislodged inside the hub.Unsure if the hemostatic valve dislodged outside the hub.The brim cap did not become detached from the sheath.The hub did not become detached from the sheath.Air entered the patient¿s body.Less than 10cc¿s of blood loss.Did not require treatment.No patient consequence.It was reported that air entered the patient; however, there were no patient consequences and no treatment required.Since the patient was asymptomatic (as implied) and the air was noticed as an observation, did not require medical or surgical intervention, there was no report of permanent impairment, no report of radiographic evidence of infarction, and no report of extended hospitalization was reported, this issue was assessed as a patient event non serious.The ¿valve on the back was leaking and there was blood backflow¿ issue was assessed as mdr reportable.
Additional Manufacturer Narrative
H6.Medical device problem code of ¿appropriate device problem term/code not available (a27)¿ represents the patient event non-serious issue.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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24866125
• Report Number: 2029046-2026-01199
• Device Sequence Number: 9367316
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: (01)10846835016260(17)280206(10)00003128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D138503
• Device Lot Number: 00003128
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 06/09/2026; 07/08/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 07/03/2026; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2026
• 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
• Patient Sex: Unknown