MAUDE Adverse Event Report: Teleflex Medical LLC. GuideLiner V3 Catheter; Catheter, Percutaneous

Model Number	5571
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Interventional procedure being performed on patient.At the end of the procedure, md was removing guide, wire, and oct catheter through the copilot.Upon opening the copilot to remove equipment, a thin, flexible piece of plastic was hanging out of the copilot.Everything was removed from the patient and flushed on the back table to see where the plastic had come from.No other pieces of plastic were noted.

• Brand Name: GuideLiner V3 Catheter
• Common Device Name: Catheter, Percutaneous
• Manufacturer (Section D): Teleflex Medical LLC.
• MDR Report Key: 50842556
• Report Number: MW6002558
• Device Sequence Number: 18655252
• Product Code: DQY
• UDI-Device Identifier: 10841156106560
• UDI-Public: (01)10841156106560
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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 Model Number: 5571
• Device Lot Number: 73F2600062
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 281 LB
• Patient Race: White