MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TRAPLINER 7F; CATHETER, PERCUTANEOUS

Catalog Number	5567
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "product separated into 2 pieces.It broke entering into the hemostasis valve.No air, particulate or component was reported entering the vasculature.No harm, injury or consequence was reported.".
Event or Problem Description
It was reported that "product separated into 2 pieces.It broke entering into the hemostasis valve.No air, particulate or component was reported entering the vasculature.No harm, injury or consequence was reported.".
Additional Manufacturer Narrative
(b)(4).The customer report that a trapliner catheter "separated into 2 pieces" was able to be confirmed through investigation of the returned sample.The customer returned one trapliner catheter for evaluation.Signs of use were observed.Visual analysis revealed complete separation of the catheter at the weld joint between the hypotube and flat push rod.The outer diameter of both the hypotube and catheter body were within specification limits.A device history record review was performed, and no relevant findings were identified.Additional information indicated that the catheter broke while being introduced to the hemostasis valve.No patient harm was reported.Based on the customer report and the sample received, unintended user error likely caused or contributed to the event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: TRAPLINER 7F
• 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: 23264420
• Report Number: 2134812-2025-00039
• Device Sequence Number: 20169060
• Product Code: DQY
• UDI-Device Identifier: 10841156100551
• UDI-Public: (01)10841156100551(11)241105(17)261105(10)73L2400230(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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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 Catalogue Number: 5567
• Device Lot Number: 73L2400230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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