MAUDE Adverse Event Report: Biosense Webster Inc VIZIGO; Introducer, Catheter

Catalog Number	D138501
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a vizigo and the hemostatic valve was dislodged inside the hub.It was reported that hemostatic valve of vizigo was damaged.The while gasket was found abnormal.Change another sheath to complete the operation.There was no adverse event reported on patient.Additional information received indicating the hemostatic valve was dislodged inside the hub and not dislodged outside of the hub.The brim cap/hub did not detach from the sheath.No air entered the patient¿s body.There was no blood loss.
Additional Manufacturer Narrative
The product has not returned for analysis, however, a picture were provided by the customer.Evaluation is still in progress.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.E1.Initial reporter phone: (b)(6).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).

• 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): VistaMed Ltd t/a Freudenberg Medical; ida business & technology park; co. leitrim, ireland.; carrick on shannon N41N8 C9; EI N41N8C9
• Manufacturer Contact: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50941966
• Report Number: 3013300026-2026-03213
• Device Sequence Number: 9498671
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: (01)10846835016253(17)280428(10)18039110
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K170997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial

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: D138501
• Device Lot Number: 18039110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2026
• 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