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

Model Number	FSC 4-75
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Perforation occurred, procedure was completed using a stent.

• Brand Name: FLEX VESSEL PREP¿ SYSTEM
• Common Device Name: PERIPHERAL INTRAVASCULAR CATHETER
• Manufacturer (Section D): VENTUREMED GROUP, INC.; 2800 campus dr.; suite 50; plymoouth 55441
• Manufacturer (Section G): VENTUREMED GROUP, INC.; 2800 campus dr.; suite 50; plymouth MN 55441
• Manufacturer Contact: timothy kappers ; 2800 campus dr.; suite 50; plymouth, MN 55441 ; 6122017450
• MDR Report Key: 22473502
• Report Number: 3012696653-2025-00003
• Device Sequence Number: 8094488
• Product Code: PNO
• UDI-Device Identifier: 00863656000325
• UDI-Public: (01)00863656000325(17)260712(10)65709
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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 Expiration Date: 07/12/2026
• Device Model Number: FSC 4-75
• Device Catalogue Number: FSC 4-75
• Device Lot Number: 65709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown