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

Model Number	IPN913565
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "when inserting a balloon into a 5f guideliner the balloon does not pass through.Removal of the guideliner reveals that it is defective and appears to be torn.Immediate action taken: replacement of the guideliner.There was no impact to the patient.".
Additional Manufacturer Narrative
Qn(b)(4).
Event or Problem Description
It was reported that: "when inserting a balloon into a 5f guideliner the balloon does not pass through.Removal of the guideliner reveals that it is defective and appears to be torn.Immediate action taken: replacement of the guideliner.There was no impact to the patient.".
Additional Manufacturer Narrative
(b)(4).The customer returned one guideliner catheter for investigation.Signs of use in the form of blood particulates were observed on the device.Visual inspection did not reveal any damage or defects on the device except a minor kink at the halfpipe.Functional testing was performed by putting a lab inventory wire guide succesfully through the guideliner.A lab inventory balloon cathter was inserted into the guideliner and successfuly passed through.A device history record review was performed, and no relevant findings were identified.The customer report of guideliner damage was not able to be confirmed through testing of the returned device.Visual inspection revealed no damage to the tip of the device.There was a minor kink at the halfpipe but its unclear if that occurred during the procedure, packing, or shipping.Functional testing was performed where both a guidewire and balloon catheter were able to be advanced through the guideliner.A device history record review was performed, and no relevant findings were identified.Based on the sample received and the customer report, no product failure was observed.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "when inserting a balloon into a 5f guideliner the balloon does not pass through.Removal of the guideliner reveals that it is defective and appears to be torn.Immediate action taken: replacement of the guideliner.There was no impact to the patient.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23987538
• Report Number: 2134812-2026-00002
• Device Sequence Number: 14626375
• Product Code: DQY
• UDI-Device Identifier: 10841156103804
• UDI-Public: (01)10841156103804(11)250118(17)270108(10)47A2500073(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K220650
• 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,Followup
• Report Date (Section B): 12/16/2025

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 Model Number: IPN913565
• Device Catalogue Number: 5569
• Device Lot Number: 47A2500073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/30/2026; 02/27/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/10/2026; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2025
• 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.; NOT REPORTED.
• Patient Sex: Unknown