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

Catalog Number	5571
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "during a coronary angiogram.Guide liner distal section after the half pipe section broken and appears squashed, pinched and diameter compromised.Guide liner inserted into a 6fr guiding catheter and got stuck and had to be forcefully pulled out to be removed.It came out in 2 parts, due to getting stuck and force used to pull out.The separation was just past the halfpipe.".
Additional Manufacturer Narrative
Qn# (b)(4).No return product evaluation could be completed as the device was not returned for investigation.A video was shared by the customer.The blue polymer was pinched proximally.The pushrod and halfpipe were missing.The coil was observed to be exposed.Unit was manufactured in tecate.A device history record (dhr) review was completed for lot 73c2400990.No issues or non-conformities were noted.Case details were reviewed.Customer stated, "guide liner distal section after the half pipe section broken and appears squashed, pinched and diameter compromised.Guide liner inserted into a 6fr guiding catheter and got stuck and had to be forcefully pulled out to be removed." no product was returned to teleflex for evaluation.A video of the issue was shared.The blue polymer was pinched proximally.The pushrod and halfpipe were missing.The coil was observed to be exposed.Additional information was requested.A response was received.Guideliner got stuck within the guide catheter.Catheter broke near the halfpipe.Both pieces were retrieved.Damages are likely due to operation against resistance.Per ifu states the following warning and precaution: 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.A manufacturing record review was completed for lot 73c2400990.No issues or non-conformities were noted.Based on the limited information, the most likely root cause of the issue is operational context and/or user error.The der process will continue to monitor and investigate any similar events.
Event or Problem Description
It was reported that: "during a coronary angiogram.Guide liner distal section after the half pipe section broken and appears squashed, pinched and diameter compromised.Guide liner inserted into a 6fr guiding catheter and got stuck and had to be forcefully pulled out to be removed.It came out in 2 parts, due to getting stuck and force used to pull out.The separation was just past the halfpipe.".

• 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: 21065004
• Report Number: 2134812-2025-00001
• Device Sequence Number: 8399094
• Product Code: DQY
• UDI-Device Identifier: 10841156109127
• UDI-Public: (01)10841156109127(11)240403(17)260327(10)73C2400990(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K172090
• 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): 12/09/2024

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: 03/27/2026
• Device Catalogue Number: 5571
• Device Lot Number: 73C2400990
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2024
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Weight: 85 KG