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

Catalog Number	D138505
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation 08-aug-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 a cardiac ablation procedure with a vizigo sheath and observed the hemostatic valve broken/cracked.Defective hemostatic valve.Confirmed upon inserting the catheter into the sheath.Replaced the vizigo sheath with another new one.The procedure was completed without patient consequence.Additional information was received on 24-jul-2025.The sheath was being used on the patient.No air entered the patient¿s body.No needle was involved in the alleged event.Additional information was received on 28-jul-2025.The hemostatic valve was broken/cracked.The hemostatic valve was not dislodged inside the sheath nor outside the sheath.The brim cap / hub did not become detached.No air entered the patient¿s body.No blood return was observed.No needle was involved in the alleged event.
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a vizigo sheath and observed the hemostatic valve broken/cracked.The device evaluation was completed on 04-sep-2025.The product was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection and microscopic examination of the returned device were performed following j&j medtech procedures.Visual analysis revealed that the hemostatic valve was dislodged inside the hub of the device.Microscopic examination of the hemostatic valve surface showed stress marks on the star section.A device history record was performed for the finished device batch number, and no internal actions were identified.The hemostatic valve separation issue reported by the customer was confirmed.The potential cause of the stress marks and separation of the hemostatic valve could be related to the incorrect insertion of the dilator into the sheath and excessive force to manipulate the device; however, this could not be conclusively determined.The instructions for use (ifu) contain the following information: 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; 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: 22783516
• Report Number: 2029046-2025-02656
• Device Sequence Number: 21308907
• Product Code: DYB
• UDI-Device Identifier: 10846835026269
• UDI-Public: (01)10846835026269(17)260912(10)60000505
• 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): 09/24/2025

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 Expiration Date: 09/12/2026
• Device Catalogue Number: D138505
• Device Lot Number: 60000505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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: QDOT MICRO, BI, TC, D-F.; UNK_NGEN RF GENERATOR.
• Patient Sex: Unknown