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

Catalog Number	D138502
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a vizigo sheath and the patient experienced vein perforation that required balloon deployment.The vizigo sheath was transeptal and when changing to a faradrive sheath, the iliac vein was perforated.The patient was hypotensive.The vizigo wire was being used at that time.The vein was reported to have been stented (then reported that an aortic balloon was used to stop the bleed).No ablation was performed.Physician¿s opinion is that something during the sheath exchange causes the incident.
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Note: for field d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50885025
• Report Number: 3013300026-2026-03145
• Device Sequence Number: 10667641
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: (01)10846835016277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: D138502
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown