MAUDE Adverse Event Report: VENTUREMED GROUP 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	Perforation of Vessels (2135)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Extravasation/perforation of a vein during a procedure treating a lesion at the transition to the subclavian vein.During operation, a vein at the transition to the subclavian vein, a perforation of the vessel occurred.Treatment with a covered stent 8mm, after dilation (approx.1 minute).

• Brand Name: FLEX VESSEL PREP SYSTEM
• Common Device Name: PERIPHERAL INTRAVASCULAR CATHETER
• Manufacturer (Section D): VENTUREMED GROUP; 2800 campus drive; suite 50; plymouth MN 55441
• Manufacturer (Section G): BIOMERICS ADVANCED CATHETER; 10351 xylon ave. n; brooklyn park MN 55445
• Manufacturer Contact: jill schweiger ; 2800 campus drive; suite 50; plymouth, MN 55441 ; 7632962021
• MDR Report Key: 19008385
• Report Number: 3012696653-2024-00001
• Device Sequence Number: 8368391
• Product Code: PNO
• UDI-Device Identifier: 00863656000325
• UDI-Public: (01)00863656000325(17)250926(10)59064
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2024

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: 09/26/2025
• Device Model Number: FSC 4-75
• Device Catalogue Number: FSC 4-75
• Device Lot Number: 59064
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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