MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MI,4FST,40CM,SS/TUN,7ECO; INTRODUCER, CATHETER

Catalog Number	7262V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "4f mik sheath separated from hub upon removal.A cutdown was performed to remove remainder of device.".
Additional Manufacturer Narrative
Qn# (b)(4).Complaint details were reviewed.Customer stated, " 4f mik sheath separated from hub upon removal".No unit was returned for evaluation.It is unknown to what extent and degree of damage was present on the unit.Additional information was requested.A response was received.Surgical cutdown was employed to remove the sheath.Based on the information, the most likely root cause of the issue is undeterminable.Teleflex will continue to monitor similar issues and trends.
Event or Problem Description
It was reported that: "4f mik sheath separated from hub upon removal.A cutdown was performed to remove remainder of device.".

• Brand Name: MI,4FST,40CM,SS/TUN,7ECO
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24660110
• Report Number: 2134812-2026-00010
• Device Sequence Number: 5079733
• Product Code: OFC
• UDI-Device Identifier: 10841156102876
• UDI-Public: (01)10841156102876(11)250918(17)280918(10)73J2500573(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/25/2026

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: 7262V
• Device Lot Number: 73J2500573
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2025
• 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; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown