MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MI,4F,40CM,NIT/SS,7CMSMT; INTRODUCER, CATHETER

Catalog Number	7248V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "hub from dilator/stylet broke off during a procedure.Medical intervention reported::broken piece was retrieved with a snare patient's current condition: fine/stable no harm or health consequences to the patient".
Event or Problem Description
It was reported that: "hub from dilator/stylet broke off during a procedure.Medical intervention reported:broken piece was retrieved with a snare patient's current condition: fine/stable.No harm or health consequences to the patient".
Additional Manufacturer Narrative
(b)(4).The customer report that the "hub from dilator/stylet broke off" was able to be confirmed through investigation of the returned sample.The customer submitted two photos and returned one dilator, one sheath, and the pouch packaging from a 4fr mik for analysis.Visual analysis revealed that the sheath body was separated from the sheath hub.Microscopic inspection of the hub revealed that no extrusion material remained attached within the hub.The proximal tip of the sheath body extrusion was not deformed or stretched, indicating a clean separation from the hub.The sheath passed relevant dimensional requirements.Additional information was requested, and a response was received.The separated portion of the sheath was retrieved using a snare.The patient's current condition is fine.There was no harm or health consequence to the patient.The manufacturing unit determined that this issue is likely related to the extruding process.Based on the customer report and the sample received, the most likely root cause is manufacturing related.Further investigation has been initiated under teleflex quality systems to evaluate this issue.

• Brand Name: MI,4F,40CM,NIT/SS,7CMSMT
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24659790
• Report Number: 2134812-2026-00009
• Device Sequence Number: 5054817
• Product Code: OFC
• UDI-Device Identifier: 10841156102784
• UDI-Public: (01)10841156102784(11)250519(17)271225(10)73E2500433(21)
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: 7248V
• Device Lot Number: 73E2500433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• 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: 03/25/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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
• Patient Sex: Unknown