MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. VENTRAX¿; VASCULAR CATHETER INTRODUCTION KIT, NON-STEERABLE

Catalog Number	VTR852
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that the sheath of the device was used for approximately five hours for a pvc ablation, no anti-coagulation was used.The patient was admitted and due to patient being deaf a stroke was not detected for 24 hours.No additional information available.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: VENTRAX¿
• Common Device Name: VASCULAR CATHETER INTRODUCTION KIT, NON-STEERABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, ut 84095 ; MX 84095
• MDR Report Key: 24571535
• Report Number: 1721504-2026-00911
• Device Sequence Number: 9561379
• Product Code: DQY
• UDI-Device Identifier: 00884450838167
• UDI-Public: 00884450838167
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K242873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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
• Device Catalogue Number: VTR852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown