MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VSI MICRO-INTRODUCER KIT; CATHETER INTRODUCER KIT

Catalog Number	7280V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the micro-introducer kit broke while our interventional radiologist was placing the catheter in the patient's right common femoral artery over a guidewire.The physician was able to retrieve the broken piece of equipment." good faith efforts were made to obtain additional information regarding the reported device issue and to assess whether any patient harm, injury, or adverse health consequences occurred.A total of three documented attempts were made to contact the user facility; however, no response or additional information was received.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: VSI MICRO-INTRODUCER KIT
• Common Device Name: CATHETER INTRODUCER KIT
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25142942
• Report Number: 2134812-2026-00022
• Device Sequence Number: 9325153
• Product Code: OFC
• UDI-Device Identifier: 10841156103019
• UDI-Public: (01)10841156103019(11)251014(17)281014(10)73K2500537(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7280V
• Device Lot Number: 73K2500537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2025
• 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: NOT REPORTED.
• Patient Sex: Unknown