MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC GUIDELINER,3.5,5F; CATHETER, PERCUTANEOUS

Catalog Number	5569
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during a pci, dr used a 5fr guideliner to help deliver a stent on a 5fr system.The guideliner snapped on the proximal end distal to the collar inside the 5fr guide while pulling it back, there was no harm to the pt, the stent was deployed successfully.".
Event or Problem Description
It was reported that: "during a pci, dr used a 5fr guideliner to help deliver a stent on a 5fr system.The guideliner snapped on the proximal end distal to the collar inside the 5fr guide while pulling it back, there was no harm to the pt, the stent was deployed successfully.".
Additional Manufacturer Narrative
Qn# (b)(4).One unit of guideliner was returned for evaluation.Severe lumen damages were observed along the length of the rx lumen.This includes separation, coil deformation & displacement, lumen crimp and collar damage.Damages observed are indicative of concomitant device interaction and/or operation against resistance.Per ifu states the following warning and precaution: never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, damage to the catheter, or vessel damage.Exercise care in handling of the catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking.Do not apply torque to the catheter during delivery, as catheter damage may result.Do not withdraw an undeployed stent back into the guideliner catheter when the catheter is in the body, as it may result in dislodging the stent.Instead, simultaneously pull both the guideliner catheter and undeployed stent back into the guide and remove together additional information was requested.A response was received.Mild calcification and tortuosity of the vessel was observed.The stent size used was 2.5 x 15 mm.The model number of the stent used is unknown.Guideliner 5f id is 0.046'(1.17mm).The crossing profile of stent catheter system for a 2.5 x1.5 mm approximately less than 1 mm.It is unlikely to be a compatibility issue.Per customer, the guideliner shaft interacted with the stent catheter system when pulled back.Stent was deployed successfully.No patient harm noted.Based on information, the most likely root cause of the issue is unintended use error.Teleflex will continue to monitor similar issues and trends.

• Brand Name: GUIDELINER,3.5,5F
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24728575
• Report Number: 2134812-2026-00012
• Device Sequence Number: 9286946
• Product Code: DQY
• UDI-Device Identifier: 10841156103804
• UDI-Public: (01)10841156103804(11)251126(17)271126(10)73L2500881(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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 Catalogue Number: 5569
• Device Lot Number: 73L2500881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown