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

Catalog Number	D138505
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 23-oct-2025.Following j&j medtech procedures, a visual inspection of the returned device was performed.Visual analysis revealed that the hemostatic valve was dislodged inside of the hub component.Microscopic examination of the hemostatic valve surface showed stress marks.The damage observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; the stress marks and physical damage observed suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.A device history record was performed for the finished device batch number, and no internal actions were identified.The damage on the hemostatic valve found could be related to the leakage reported by the customer; therefore, the customer complaint is confirmed.The instructions for use (ifu) contain the following information: before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulates.After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli.Use best practices for inserting or retracting any device at the hemostatic valve.Monitor any potential air entrapped and completely aspirate any observed air out of the side port.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released 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).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a vizigo sheath and a hemostatic valve leakage issue was observed.Initially it was reported that the valve of the vizigo short was defective.Timing was after the sheath was inserted and when the catheter was inserted.The issue was resolved by replacing the sheath with another new one.The procedure was completed without patient's consequence.Additional information was received on 05-oct-2025.The section that the issue was observed was the hemostatic valve.The sheath was being used on the patient.No air entered the patient¿s body.No blood return was observed.No needle was involved in the alleged event.Additional information was received on 23-oct-2025.The section that the issue was observed was the hemostatic valve and the issue was leakage.The hemostatic valve did not dislodge inside the hub nor outside of the hub.The brim cap / hub did not become detached from the sheath.The hemostatic valve defective issue was originally considered non-reportable; however, bwi became aware on 23-oct-2025 of a leakage issue with the hemostatic valve and have reassessed the event as reportable.The awareness date for this record is 23-oct-2025.

• 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: 23563292
• Report Number: 2029046-2025-03818
• Device Sequence Number: 9858866
• Product Code: DYB
• UDI-Device Identifier: 10846835026269
• UDI-Public: (01)10846835026269(17)260912(10)60000505
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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 Expiration Date: 09/12/2026
• Device Catalogue Number: D138505
• Device Lot Number: 60000505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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: QDOT MICRO, BI, TC, D-F; UNK CABLE
• Patient Sex: Unknown