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
The bwi product analysis lab received the device for evaluation on 16-dec-2025.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 an atrial fibrillation (afib) procedure with a vizigo sheath and air was confirmed inside of the side tube and the port with the hemostatic valve.Every time the catheter was inserted, a large amount of air was drawn into the vizigo sheath.Timing was after the brockenbrough.The issue began and continued since the varipulse catheter was advanced through the vizigo sheath.Although air was drawn into the sheath each time the catheter was switched, air was aspirated with meticulous care, and the vizigo sheath was used as it was.The procedure was completed successfully.There was no patient consequence reported.Additional information was received on 25-nov-2025.Air was confirmed inside of the side tube and the port with hemostatic valve of the vizigo sheath.Additional information was received on 01-dec-2025.Air was not introduced into the patient.Air was meticulously aspirated.The sheath was used until the end of the procedure without being replaced.No medical intervention required.The patient did not exhibit any neurological symptoms since the procedure was completed.Additional information was received on 11-dec-2025.The fkd rf needle for atrial septum.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a vizigo sheath and air was confirmed inside of the side tube and the port with the hemostatic valve.The device evaluation was completed on 17-dec-2025.The device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection, back pressure test, and microscopic examination of the returned device were performed following j&j procedures.Visual analysis of the returned sample revealed that no damage was observed.Microscopic examination of the hemostatic valve surface does not show stress marks on the outer diameter.A back pressure test was performed, and no issues were observed.A device history record was performed, and no internal actions related to the reported complaint were identified.Since no leakage, bubbles, or air were observed; the complaint was not confirmed.The leak issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.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 particulates.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 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: 23825832
• Report Number: 2029046-2025-04194
• Device Sequence Number: 9268195
• 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): 01/14/2026

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
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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.; FKD RF NEEDLE FOR ATRIAL SEPTUM.; UNK_OCTARAY NAV.
• Patient Sex: Unknown