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

Catalog Number	D138503
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
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 a cardiac ablation procedure and when the medical team opened the vizigo sheath packaging, the medical team noted a white plastic substance inside of the valve.The device was replaced and the procedure continued.No patient consequences were reported.
Additional Manufacturer Narrative
On 5-jan-2026, the product investigation was completed.Per internal review on that same date (5-jan-2026), it was identified that the product receipt was mistakenly omitted from the previous initial report.As a result, section d9 has been updated with the product receipt of 9-dec-2025.It was reported that a patient underwent a cardiac ablation procedure and when the medical team opened the vizigo sheath packaging, the medical team noted a white plastic substance inside of the valve.The device was replaced and the procedure continued.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection and microscopic examination were performed of the returned device were performed following j&j procedures.Visual analysis revealed that the hemostatic valve was dislodged inside of the hub component.Microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter, suggestive that excessive force manipulation was applied.This failure mode could be related to the issue reported by the customer.No original packaging was returned to analysis site.A device history record evaluation was performed for the finished device lot number 00002993, and no internal actions related to the reported complaint condition were identified.The hemostatic valve issue reported by the customer was confirmed.The potential cause of the damage could be related to the incorrect insertion of the dilator into the sheath, due to an unintended use error; however this could not be conclusively determined.The instructions for use contain (ifu) the following precautions: 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.Do not remove the dilator or catheter rapidly.Damage to the hemostatic valve may occur.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.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 johnson & johnson medtech's 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 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: 23771778
• Report Number: 2029046-2025-04090
• Device Sequence Number: 9722821
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: (01)10846835016260(17)260717(10)00002993
• 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
• Report Date (Section B): 01/23/2026

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 Expiration Date: 07/17/2026
• Device Catalogue Number: D138503
• Device Lot Number: 00002993
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CARTO 3 SYSTEM; NGEN SYSTEM.; NUVISION NAV ULTRASOUND CATHETER.; THERMOCOOL SMARTTOUCH.
• Patient Sex: Unknown