MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC GUIDELINER,3.5,6F; CATHETER, PERCUTANEOUS

Catalog Number	5571
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when delivering a device into the guideliner, the guideliner got broken/cut.Therefore, the guideliner was removed and replaced with another device of the other company to complete the procedure.No injury to the patient occurred.The device that was being delivered in the guideliner.The device that was replaced from the guideliner to complete the procedure.The patient information (gender, age, weight, etc.) is not available.
Additional Manufacturer Narrative
Qn#(b)(4).One unit of guideliner was returned for evaluation.Blood particulates were noted on the unit.Unit was decontaminated and inspected.The guideliner rx lumen was severely damaged, crimped and separated into two pieces.Coil was observed to be unraveled.A device history record (dhr) review was completed for lot 47d2401356.No related non-conformances, deviations or capas were noted.Complaint details were reviewed.Customer stated, "when delivering a device into the guideliner, the guideliner got broken/cut." one unit of guideliner was returned for evaluation.The rx lumen was observed to be separated into two pieces.Severe shaft damages were observed with the coil unraveled.Damages are likely to have occurred during use when operated against resistance.The instructions for use (ifu) states the following: 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.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.Additional information was requested.A response was received.Pieces were retrieved without the use of snare.The device that was attempted to be introduced via the guideliner is unknown.The damages are indicative of concomitant device interaction and use against resistance.A manufacturing record review was completed for lot 47d2401356.No issues or non-conformities were noted.Based on the information, the most likely root cause of the issue is operational context and/or user error.The der process will continue to monitor for any similar events.
Additional Manufacturer Narrative
Qn #: (b)(4).
Event or Problem Description
It was reported that "when delivering a device into the guideliner, the guideliner got broken/cut.Therefore, the guideliner was removed and replaced with another device of the other company to complete the procedure." no injury to the patient occurred.The device that was being delivered in the guideliner.The device that was replaced from the guideliner to complete the procedure.The patient information (gender, age, weight, etc.) is not available.

• Brand Name: GUIDELINER,3.5,6F
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21751386
• Report Number: 2134812-2025-00008
• Device Sequence Number: 12820979
• Product Code: DQY
• UDI-Device Identifier: 10841156100605
• UDI-Public: (01)10841156100605(11)240425(17)260425(10)47D2401356(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172090
• 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): 03/11/2025

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: 04/25/2026
• Device Catalogue Number: 5571
• Device Lot Number: 47D2401356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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