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	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biosense webster, inc.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 premature ventricular contraction ablation procedure with a vizigo and the physician pointed out that reverse blood from the suctioning port of the vizigo sheath could not be stopped.It occurred after the brockenbrough.The issue was improved by replacing the vizigo sheath with a new one.No adverse patient consequence was reported.Additional information was received which indicated that the sheath was being used on the patient.No air entered the patient¿s body.Blood return was observed and a few drops of blood was lost, but the exact amount is unknown.
Additional Manufacturer Narrative
It was reported that a patient underwent a premature ventricular contraction ablation procedure with a vizigo and the physician pointed out that reverse blood from the suctioning port of the vizigo sheath could not be stopped.Device investigation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and irrigation test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.The brim cap, hemostatic valve, and silicone ring were placed in their original place.Afterward, the sheath was blocked at the distal end and then pressurized at both positive and negative pressure, and no issues were observed.No dislodgement, air leaks, bubbles, or other failures with the hemostatic valve were observed during the test.A device history record evaluation was performed for the finished device lot number and no internal action was found during the review.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.The hemostatic valve leak reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the use of the device that may have affected 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 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.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: 23375839
• Report Number: 2029046-2025-03544
• Device Sequence Number: 8870865
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: (01)10846835016260(17)270618(10)00002967
• 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): 11/24/2025

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: 00002967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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