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

Catalog Number	D138505
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a vizigo and when inserting the dilator, before inserting into intracardiac, the hemostatic valve was broken.The vizigo sheath was replaced with a sheath from another company.The procedure was successfully completed without patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a vizigo and when inserting the dilator, before inserting into intracardiac, the hemostatic valve was broken.The product was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection, irrigation and microscopic examination of the returned device were performed following johnson & johnson medtech procedures.Visual analysis no damage or anomalies on the device.An irrigation test was performed, and water leakage was observed.A microscopic examination of the hemostatic valve surface showed stress marks close to the star section.A device history record was performed for the finished device batch number, and no internal actions were identified.The hemostatic valve issue reported by the customer was confirmed.The broken condition could be related to the incorrect insertion of the dilator into the sheath; the stress marks and physical damage observed suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.The instructions for use (ifu) contain the following information: use best practices for inserting or retracting any device at the hemostatic valve.Do not remove the dilator or catheter rapidly.Damage to the hemostatic valve may occur.Slowly remove or insert the dilator or other devices.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (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: 22869547
• Report Number: 2029046-2025-02790
• Device Sequence Number: 21116354
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/19/2025
• 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
• Patient Sex: Unknown