MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TURNPIKE LP 150CM; CATHETER, PERCUTANEOUS

Catalog Number	5639
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "tip fracture in cto case.There was no reported harm or health consequences to the patient.Procedure was a multi-vessel diseased, in-stent restenosis in the lad cto.There was a tip fractured that separated and was left in the distal lad.".
Additional Manufacturer Narrative
(b)(4).The customer report of the turnpike tip fracture was confirmed through investigation of the returned unit.Visual analysis revealed damage to the tip where the ptfe liner was exposed and scuffing was seen on the black portion of the turnpike tip.This damage is consistent with over-torquing.The product ifu states."do not rotate the catheter more than two (2) consecutive 360 rotations in either direction if the distal tip becomes lodged and is not also rotating, as it may result in separation of the catheter, damage to the catheter, or vessel injury.If using the turnpike or turnpike lp, unwind the catheter to its relaxed position and apply backward tension in order to dislodge the tip.If using the turnpike spiral or turnpike gold, rotate the catheter in the counter-clockwise direction with backward tension in order to dislodge the tip".Additional information was received from the customer that the patient was stable after the procedure and the remaining piece of the tip was left in the distal lad.Based on the customer report and returned device, the probable cause is likely unintentional user error.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: TURNPIKE LP 150CM
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23298766
• Report Number: 2134812-2025-00040
• Device Sequence Number: 20033220
• Product Code: DQY
• UDI-Device Identifier: 10841156100698
• UDI-Public: (01)10841156100698(11)250605(17)270605(10)73F2500035(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2025

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 Catalogue Number: 5639
• Device Lot Number: 73F2500035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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
• Patient Sex: Unknown