MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC GUIDELINER COAST 3.5, 6F; CATHETER, PERCUTANEOUS

Catalog Number	5271
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "when inserting the guideliner into the coronary artery, it got broken/separated.Therefore, the guideliner was removed and replaced with a guide extension of the other company to complete the procedure.No injury to the patient occurred.".
Additional Manufacturer Narrative
(b)(4).Udi will be provided with the follow up report.
Event or Problem Description
It was reported that: "when inserting the guideliner into the coronary artery, it got broken/separated.Therefore, the guideliner was removed and replaced with a guide extension of the other company to complete the procedure.No injury to the patient occurred.".
Additional Manufacturer Narrative
Qn #: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: GUIDELINER COAST 3.5, 6F
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 21847727
• Report Number: 2134812-2025-00010
• Device Sequence Number: 18347246
• Product Code: DQY
• UDI-Device Identifier: 10841156108922
• UDI-Public: (01)10841156108922(11)240429(17)260429(10)47D2401346(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K220647
• 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): 03/25/2025

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 Expiration Date: 04/29/2026
• Device Catalogue Number: 5271
• Device Lot Number: 47D2401346
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2024
• 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 Sex: Unknown