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

Model Number	FSC 4-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after application with flex, a pseudoaneurysm with contrast medium leakage forms after the actual stenosis in the straight segment.Even inserting an occlusion balloon cannot stop the bleeding, which is why surgical intervention was necessary.During the open procedure, the surgeon described this rupture as a slit several cm (approx.4 cm) long.

• Brand Name: FLEX VESSEL PREP SYSTEM
• Common Device Name: PERIPHERAL INTRAVASCULAR CATHETER
• Manufacturer (Section D): VENTUREMED GROUP, INC.; 2800 campus dr.; suite 50; plymouth MN 55441
• Manufacturer (Section G): VENTUREMED GROUP, INC.; 2800 campus dr.; suite 50; plymouth MN 55441
• Manufacturer Contact: jill schweiger ; 2800 campus dr.; suite 50; plymouth, MN 55441 ; 7632962021
• MDR Report Key: 21412984
• Report Number: 3012696653-2025-00001
• Device Sequence Number: 8316906
• Product Code: PNO
• UDI-Device Identifier: 00863656000318
• UDI-Public: (01)00863656000318(17)260328(10)63495
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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: 03/28/2026
• Device Model Number: FSC 4-40
• Device Catalogue Number: FSC 4-40
• Device Lot Number: 63495
• 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: 01/23/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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: GUIDEWIRE; PTA BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown