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

Model Number FSC 4-75

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 02/29/2024

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 338981044
• Report Number: 3012696653-2024-00001
• Device Sequence Number: 1
• Product Code: PNO
• UDI-Device Identifier: 00863656000325
• UDI-Public: (01)00863656000325(17)250926(10)59064
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K202187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: FSC 4-75
• Device Catalogue Number: FSC 4-75
• Device Lot Number: 59064
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention