MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MI,4F,40CM,NIT/TUN7CMECO; INTRODUCER, CATHETER

Catalog Number	7280V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "they were accessing the ij for a tavr procedure.Everything went well with the stick when the went to upsize the sheath and place the.035 in the hub.As they got though the hub and into the sheath it disconnect the sheath from the hub leaving the sheath in the patient.They had to use a snare to remove the sheath from the patient.".
Additional Manufacturer Narrative
Qn# (b)(4).One-unit of mik hub, dilator and guidewire were returned to teleflex for evaluation.The shaft was separated from the hub.The separation appears to be a clean break from the hub.Unit was manufactured at tecate.A device history record (dhr) review was completed.No issues or nonconformances were noted for the lot.Complaint was escalated to non-conformance for further investigation, lot review and other testing.Based on the product evaluation, the shaft is likely is not bond correctly to the hub.Tecate was notified of the complaint and non-conformance was opened for further investigation, lot review and other testing.The case details were reviewed.Based on the product evaluation, the shaft is likely is not bond correctly to the hub.Tecate was notified of the complaint and non-conformance was opened for further investigation, lot review and other testing.The der process will continue to monitor for any similar events.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that: "they were accessing the ij for a tavr procedure.Everything went well with the stick when the went to upsize the sheath and place the.035 in the hub.As they got though the hub and into the sheath it disconnect the sheath from the hub leaving the sheath in the patient.They had to use a snare to remove the sheath from the patient.".

• Brand Name: MI,4F,40CM,NIT/TUN7CMECO
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20878549
• Report Number: 2134812-2024-00056
• Device Sequence Number: 15692208
• Product Code: DYB
• UDI-Device Identifier: 10841156106980
• UDI-Public: (01)10841156106980(11)240610(17)270618(10)73F2400359(21)
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7280V
• Device Lot Number: 73F2400359
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: 63 YR
• Patient Sex: Female