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

Catalog Number	D138503
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a vizigo sheath and slight blood leakage from the hemostatic valve was observed.The report indicated that when inserting the vizigo into the patient, the doctor commented that slight blood leakage from the hemostatic valve could be observed.It occurred within ten minutes after the sheath was used.When a catheter was inserted into the sheath, the reported sheath was flushed; however, no air could be confirmed.Therefore, the physician decided to use the sheath continuously.The procedure was successfully completed using the reported sheath.The hemostatic valve itself was not obviously broken/cracked visually.Additional information indicated that the sheath was being used on the patient.No air entered the patient¿s body and blood return was observed.A few drops of blood were lost; however, the exact amount is unknown.No needle product was used with the vizigo sheath.No adverse patient consequence was 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
The device was returned to johnson & johnson medtech (j&j) for evaluation.Therefore, section d9 has been populated.It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a vizigo sheath and slight blood leakage from the hemostatic valve was observed.Device investigation details: 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 force manipulation was applied.Finally, a back pressure test was performed, and a leakage was identified through the hemostatic valve.In addition, bubbles were identified while a negative back pressure test was performed.A device history record was performed for the finished device batch number, and no internal actions were identified.The damage observed on valve could cause the leak issue 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: 24381789
• Report Number: 2029046-2026-00546
• Device Sequence Number: 10518584
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: (01)10846835016260(17)270916(10)00003037
• 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): 03/18/2026

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: D138503
• Device Lot Number: 00003037
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• 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
• Patient Sex: Unknown