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

Catalog Number	D138505
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A device history record review was performed for the finished device lot number 60000435 and no internal actions related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.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.After puncture of femoral site, when inserting the wire, it got stuck in the dilator and could not be removed.There was no error code.The issue was resolved by replacing vizigo sheath with another new one.There was no patient consequence reported.
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a vizigo sheath.After puncture of femoral site, when inserting the wire, it got stuck in the dilator and could not be removed.There was no error code.The issue was resolved by replacing vizigo sheath with another new one.There was no patient consequence reported.The device was returned to johnson & johnson medtech (j&j) for evaluation on 16-dec-2025.A visual inspection of the returned device was performed following j&j procedures.The device was inspected, and no physical damage was observed.The customer referred that the wire got stuck in the dilator, however, the dilator and the guidewire were not returned for analysis.Due to this condition, further investigation was not possible to be performed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The wire issue reported by the customer was not confirmed, due to the guidewire was not returned for analysis.The potential cause of the issue cannot be established.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: 22800133
• Report Number: 2029046-2025-02682
• Device Sequence Number: 8314905
• Product Code: DYB
• UDI-Device Identifier: 10846835026269
• UDI-Public: (01)10846835026269(17)260612(10)60000435
• 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): 01/13/2026

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 Expiration Date: 06/12/2026
• Device Catalogue Number: D138505
• Device Lot Number: 60000435
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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
• Patient Sex: Unknown