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

Catalog Number	5271
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during a stemi pci through a calcified tortuous vessel.They tried to deploy a stent.They used a guideliner coast in this case.The stent was deployed, balloon ruptured in the guideliner and part of the stent balloon was left in the patient that required to be snared.No harm to the patient.The doctor stated that they don't think it was caused by guideliner, it may have been related to severe calcium and tortuousity.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during a stemi pci through a calcified tortuous vessel.They tried to deploy a stent.They used a guideliner coast in this case.The stent was deployed, balloon ruptured in the guideliner and part of the stent balloon was left in the patient that required to be snared.No harm to the patient.The doctor stated that they don't think it was caused by guideliner, it may have been related to severe calcium and tortuosiy.".
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.Additional information indicated that the patient had no harm.A stemi pci was being performed.The balloon ruptured inside the guidewire.The vessel was tortuous and severely calcified.The doctor does not think the issue was caused by the guideliner rather due to the severe calcification and tortuosity.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 COAST 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
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23435695
• Report Number: 2134812-2025-00041
• Device Sequence Number: 4758985
• Product Code: DQY
• UDI-Device Identifier: 10841156109028
• UDI-Public: (01)10841156109028(11)240422(17)260422(10)47D2401171(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220647
• 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): 10/06/2025

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: 04/22/2026
• Device Catalogue Number: 5271
• Device Lot Number: 47D2401171
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2024
• 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.
• Patient Sex: Unknown