MAUDE Adverse Event Report: VENTUREMED GROUP, INC. FLEX VESSEL PREP SYSTEM; PERIPHERAL INTRAVASCULAR CATHETER

Model Number	FSC 4-75
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Vessel dissection noted by physician leading to further interventional procedures to complete the procedure.No other information given.

• Brand Name: FLEX VESSEL PREP SYSTEM
• Common Device Name: PERIPHERAL INTRAVASCULAR CATHETER
• Manufacturer (Section D): VENTUREMED GROUP, INC.; 2800 campus drive; suite 50; plymouth MN 55441
• Manufacturer (Section G): VENTUREMED GROUP, INC.; 2800 campus dr; suite 50; plymouth 55441
• Manufacturer Contact: timothy kappers ; 2800 campus dr; suite 50; plymouth 55441 ; 6122017450
• MDR Report Key: 23689052
• Report Number: 3012696653-2025-00005
• Device Sequence Number: 21426506
• Product Code: PNO
• UDI-Device Identifier: 00863656000325
• UDI-Public: (01)00863656000325(17)261108(10)65718
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K202187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/01/2025

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?: No
• Device Model Number: FSC 4-75
• Device Catalogue Number: FSC 4-75
• Device Lot Number: 65718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown