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

Catalog Number	D138505
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a vizigo sheath and post procedure the bwi product analysis lab identified that the brim cap was detached from the device and the silicon ring and hemostatic valve were detached.The silicon ring and hemostatic valve components were not returned to bwi.During the procedure, the parts of the inserting port for the catheter of the vizigo short had an issue--the optrell catheter could not be inserted into the sheath.This occurred over two hours into the device's first use.No visible damages or dislodgments were noted to the hemostatic valve, brim cap, or hub at the time.No air entered the patient's body.The issue was handled by replacing the sheath with another new one.The procedure was completed without patient's consequence.
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection evaluation test of the returned device was performed following johnson & johnson medtech procedures.Visual analysis of the returned sample revealed that the brim cap was detached from the device and the silicon ring and hemostatic valve were not returned by the customer.A device history record review was performed for the finished device 60000459 number, and no internal actions related to the complaint were found during the review.The complaint was confirmed since the brim cap detached issue observed during the investigation could be related to the reported event.The potential cause of this type of failure could be related to the manipulation of the device after the procedure however, this cannot 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 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: pc-(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: 23659215
• Report Number: 2029046-2025-03945
• Device Sequence Number: 10123631
• Product Code: DYB
• UDI-Device Identifier: 10846835026269
• UDI-Public: (01)10846835026269(17)260718(10)60000459
• 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
• Report Date (Section B): 11/26/2025

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 Expiration Date: 07/18/2026
• Device Catalogue Number: D138505
• Device Lot Number: 60000459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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: OPTRELL CATHETER.
• Patient Sex: Unknown