MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TRAPLINER 8F; CATHETER, PERCUTANEOUS

Catalog Number	5568
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "upon removal from the hoop, the trapliner was found to be in two separate pieces.Another trapliner was used successfully." the issue was identified prior to use, there was no patient involved.
Additional Manufacturer Narrative
Qn#(b)(4).The reported issue of trapliner body separation was confirmed through investigation of the returned sample.The customer returned one unit of trapliner, and the visual inspection revealed a weld joint separation.It is unknown if the trapliner was broken during preparation prior to use or during introduction within the guide catheter.A review of the manufacturing process confirmed that the trapliner undergoes various inspections processes for defects and the units are scrapped if weld joint separation is noted.A device history record review was performed, and no relevant findings were identified.Based on the information, the root cause of this reported issue could not be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "upon removal from the hoop, the trapliner was found to be in two separate pieces.Another trapliner was used successfully." the issue was identified prior to use; there was no patient involved.

• Brand Name: TRAPLINER 8F
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21992540
• Report Number: 2134812-2025-00020
• Device Sequence Number: 12904683
• Product Code: DQY
• UDI-Device Identifier: 10841156100568
• UDI-Public: (01)10841156100568(11)240715(17)260715(10)47G2400230(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161901
• 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): 05/01/2025

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: 07/15/2026
• Device Catalogue Number: 5568
• Device Lot Number: 47G2400230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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
• Patient Sex: Unknown