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

Catalog Number	D138503
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 9 december 2025, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a vizigo and a clear, stringy, fibrous part of the optrell came out of the sheath.It was reported that when the optrell was removed from the vizigo sheath, a clear, stringy, fibrous part of the optrell came out of the sheath.There was no physical damage noticed on the optrell catheter.A pre-shaped needle was used.The physician was finished with the optrell at that time but replaced the vizigo sheath out of an abundance of caution.There were no patient consequences reported.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a vizigo and a clear, stringy, fibrous part of the optrell came out of the sheath.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection and microscopic examination of the returned device was performed following j&j procedures.Visual inspection revealed no anomalies or physical damage on the device; no exposed components were identified.Then, a good known lab sample dilator was introduced and unusual resistance was felt in the tip area of the sheath.Due to the customer reporting a foreign fibrous material on the device, the shaft was inspected from the inside and the liner material of the vizigo was found torn off the inner walls of the sheath.After that, the shaft was dissected and scratches on the internal polytetrafluoroethylene (ptfe) liner of the shaft were observed at the tip area.The foreign fibrous part reported by the customer could be related to polytetrafluoroethylene (pt-fe); however, this cannot be conclusively determined.A device history record was performed for the finished device batch number, and no internal actions were identified.The damage observed inside the shaft could be related to the exposed component reported by the customer; therefore, the complaint was confirmed.The potential cause of this issue could not be established.The instructions for use contain the following recommendations: prior to inserting the device into the patient, pre-assemble sheath, dilator and stylet on the table.Advance the needle through the dilator and check for excessive resistance as the tip of the needle advances through the curvature of the sheath/dilator assembly.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 ref.# (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: 23777584
• Report Number: 2029046-2025-04101
• Device Sequence Number: 9933887
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: (01)10846835016260(17)260423(10)00002933
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 04/23/2026
• Device Catalogue Number: D138503
• Device Lot Number: 00002933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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: BAYLIS VERSACROSS NEEDLE.; OPTRELL, 48 ELECTRODES, D-F.; UNK_ SMARTABLATE SYSTEM.; UNK_CARTO 3.
• Patient Sex: Unknown