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

Catalog Number	D138505
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a ventricular tachycardia ablation procedure with a vizigo sheath and a significant amount of air was drawn from the side port.After the optrell was removed from the vizigo short, and the qdot micro catheter was inserted into the vizigo short, the issue occurred while air was being drawn.No air was introduced into the patient and no medical intervention was required.The hemostatic valve was not damaged.After that, air was fully removed.The sheath was used carefully, and the procedure was completed successfully.No patient consequences were reported.
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).
Additional Manufacturer Narrative
On (b)(6) 2026, bwi received additional information indicating that a fkd rf needle for atrial septum was used.This has been added to the concomitant products section.Furthermore, on (b)(6) 2026, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent a ventricular tachycardia ablation procedure with a vizigo sheath and a significant amount of air was drawn from the side port.After the optrell was removed from the vizigo short, and the qdot micro catheter was inserted into the vizigo short, the issue occurred while air was being drawn.No air was introduced into the patient and no medical intervention was required.The hemostatic valve was not damaged.After that, air was fully removed.The sheath was used carefully, and the procedure was completed successfully.No patient consequences were reported.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the vizigo sheath.Back pressure test was performed, and water leakage was observed coming through the hemostatic valve.A microscopic examination of the hemostatic valve surface showed stress marks and leaflets bent.This 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.A device history review was performed for the finished device 60000650 number, and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.The potential cause of the valve issue could be related to the handling of the device during the procedure; however, this could not be conclusively determined.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 particulate.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.Once the sheath is inserted into the vasculature and the dilator is removed, aspirate until steady blood return is achieved prior to flushing or infusion.All fluid infusion should be through the side port.In order to minimize the risk of air embolism provide a continuous infusion of heparinized saline solution once the sheath is inserted into the patient.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.This product issue will be addressed through j&j medtech's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: 23874946
• Report Number: 2029046-2025-04274
• Device Sequence Number: 10465433
• Product Code: DYB
• UDI-Device Identifier: 10846835026269
• UDI-Public: (01)10846835026269(17)270305(10)60000650
• 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,Followup
• Report Date (Section B): 02/04/2026

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: D138505
• Device Lot Number: 60000650
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FKD RF NEEDLE FOR ATRIAL SEPTUM; UNK_OPTRELL MAPPING CATHETER; UNK_QDOT MICRO
• Patient Sex: Unknown