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

Catalog Number	7266V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the mik was broken at the hub.The issue was identified during use on patient but there was no reported patient harm or consequence.They were reported as fine.
Event or Problem Description
It was reported that: the mik was broken at the hub.The issue was identified during use on patient but there was no reported patient harm or consequence.They were reported as fine.
Additional Manufacturer Narrative
(b)(4).One-unit of mik was returned to teleflex for evaluation.Minor blood particulates were noted on the unit.No hub separation or damages were noted on both sheath and dilator.Case details were reviewed.Customer stated "broken mik at the hub".The access site was reported as femoral in the additional information.No information on vessel factors such as scar tissue, tortuosity and calcification were provided.Another device was used to complete the case.Based on the product return, no hub damages were noted.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue is undeterminable.No product failure noted.The der process will continue to monitor for any similar events.

• Brand Name: VSI MICRO-INTRODUCER KITS
• 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: 18334264
• Report Number: 2134812-2023-00057
• Device Sequence Number: 8489251
• Product Code: DYB
• UDI-Device Identifier: 10841156102913
• UDI-Public: 10841156102913
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 7266V
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 64 YR
• Patient Sex: Male