MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MI,4F,60CM,SS/SS,7CMECO; INTRODUCER, CATHETER

Catalog Number	7243V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the physician obtained access to the rcfa when he attached the syringe to the micro sheath and pulled negative, he noticed bubbles.When he attempted to withdraw the sheath, it was separated from the hub.He removed the sheath without incident.Another device was used successfully.".
Event or Problem Description
It was reported that: "the physician obtained access to the rcfa when he attached the syringe to the micro sheath and pulled negative, he noticed bubbles.When he attempted to withdraw the sheath, it was separated from the hub.He removed the sheath without incident.Another device was used successfully.".
Additional Manufacturer Narrative
(b)(4).The customer report that the sheath separated from the hub was able to be confirmed through the review of the customer supplied photo.The photograph portrays a clean break from the sheath and hub.A device history review was performed and there were no relevant findings.The manufacturing unit confirmed that the most likely root cause is manufacturing related--specifically extrusion related.Further investigation has been initiated under teleflex quality systems to evaluate this issue.

• Brand Name: MI,4F,60CM,SS/SS,7CMECO
• 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: 24504635
• Report Number: 2134812-2026-00005
• Device Sequence Number: 13365910
• Product Code: OFC
• UDI-Device Identifier: 10841156103262
• UDI-Public: (01)10841156103262(11)251012(17)281012(10)73K2500538(21)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 02/10/2026

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: 7243V
• Device Lot Number: 73K2500538
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2025
• 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