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	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2025, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 air was drawn from the sheath after inserting the octaray catheter.To perform additional ablations, the sheath was replaced when re-inserting the varipulse catheter.No hemostatic valve damage was noticed on the replaced sheath.The procedure continued.The procedure was successfully completed.No patient consequences were reported.
Additional Manufacturer Narrative
On 17-dec-2025, the product investigation was completed.It was reported that a patient underwent a cardiac ablation procedure with a vizigo sheath and air was drawn from the sheath after inserting the octaray catheter.To perform additional ablations, the sheath was replaced when re-inserting the varipulse catheter.No hemostatic valve damage was noticed on the replaced sheath.The procedure continued.The procedure was successfully completed.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection and microscopic examination of the returned device were performed following j&j procedures.Visual analysis revealed that the hemostatic valve was broken in the star section.Microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The stress marks and physical damage observed suggest that excessive fore manipulation was applied.Finally, a back pressure test was performed, and a leakage was identified through the hemostatic valve.In addition bubbles were identify while a negative back pressure test was performed.A device history review was performed for the finished device (b)(6) number, and no internal actions related to the complaint were found during the review.The damage observed on valve could cause the air and leak issues reported by the customer; therefore, the complaint 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: 23821384
• Report Number: 2029046-2025-04165
• Device Sequence Number: 9422988
• 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): 01/13/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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: 8.5 FR VARIPULSE CATHETER; UNK_OCTARAY NAV
• Patient Sex: Unknown