MAUDE Adverse Event Report: Teleflex Medical LLC GuideLiner,3.5,7F; CATHETER, PERCUTANEOUS

Catalog Number	5572
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction

• Brand Name: GuideLiner,3.5,7F
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): Teleflex Medical LLC; morrisville NC
• Manufacturer (Section G): Vascular Solutions LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: angela meister ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 50950924
• Report Number: 2134812-2026-00048
• Device Sequence Number: 10452148
• Product Code: DQY
• UDI-Device Identifier: 10841156110468
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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
• Device Catalogue Number: 5572
• Device Lot Number: 47A2500677
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2025
• 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
• Patient Sex: Unknown