MAUDE Adverse Event Report: Vascular Solutions LLC VSI Micro-Introducer Kits 5FST,40cm,Nit/SS,7SM; WIRE, GUIDE, CATHETER

Catalog Number	7271V
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Malfunction

• Brand Name: VSI Micro-Introducer Kits 5FST,40cm,Nit/SS,7SM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): Vascular Solutions LLC; minneapolis MN
• Manufacturer (Section G): Teleflex Medical; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 50022590
• Report Number: 9680794-2026-00539
• Device Sequence Number: 15836500
• Product Code: DQX
• UDI-Device Identifier: 10841156102951
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K021990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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
• Device Catalogue Number: 7271V
• Device Lot Number: 73B2601017
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2026
• 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
• Patient Sex: Unknown