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	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the trap liner was advanced too far exposing the collar outside of the guide catheter.When realized physician attempted to correct and pull back into the guide catheter causing the trapliner to break into pieces at the flex point while crossing the vd-om.Catheter was retrieved successfully with a guide liner and balloon and procedure was completed.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the customer report of the trapliner breaking into two pieces was able to be confirmed with inspection of the returned sample.The customer returned one trapliner device separated into two pieces.Signs of use in the form of blood particulates were noted on the device.Catheter shaft damage (i.E., collaring, coil deformation, and kinking) was noted on the returned device.Visual analysis revealed separation at the weld joint and catheter shaft damage in multiple places along its length.A device history record review was performed and there were no relevant findings.Additional information indicated that "the trapliner was advanced too far exposing the collar outside of the guide catheter.When realized physician attempted to correct and pull back into the guide catheter causing the trapliner to break at the flex point.".The product ifu states "never advance the trapliner catheter more than 10cm beyond the tip of the guide catheter, as the trapliner catheter may become lodged in the guide catheter making it difficult to remove".Based upon the damage observed, unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported that: "the trapliner was advanced too far exposing the collar outside of the guide catheter.When realized physician attempted to correct and pull back into the guide catheter causing the trapliner to break into pieces at the flex point while crossing the vd-om.Catheter was retrieved successfully with a guideliner and balloon and procedure was completed.".

• 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: 23494576
• Report Number: 2134812-2025-00045
• Device Sequence Number: 8993293
• Product Code: DQY
• UDI-Device Identifier: 10841156100568
• UDI-Public: (01)10841156100568(11)241211(17)261211(10)47M2400093(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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 5568
• Device Lot Number: 47M2400093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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