MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TURNPIKE SPIRAL 135CM; CATHETER, PERCUTANEOUS

Catalog Number	5640
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer report of the turnpike tip separating was confirmed by visual inspection of the customer supplied photos and the returned device.Visual analysis revealed the returned unit was kinked on the shaft.The remaining part of the tip was severely damaged.The ptfe liner was exposed on the distal portion of the tip and the metal braid was completely severed in the lumen.No defects or damage were observed on any other portion of the returned device.Angiograms provided by the customer reveal the heavily calcified portion of the vessel and the location of the severed tip inside the patient.A device history record review was performed, and no relevant findings were identified.Additional information was received that it was unknown whether the turnpike spiral was used per the ifu or torqued excessively.Patient's current condition is fine but tip is still trapped in lesion in left circumflex artery.R & d engineering was contacted about this complaint.They confirmed that the damage seen is consistent with over-torqueing the device.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.
Event or Problem Description
It was reported that: "calcified cx, tp spiral was used to deliver over floppy wire to help with wire exchange and the tip got stuck in the calcium and separated from the catheter.Dr.Was unable to snare the device or get a wire next to the tip to help remove it.2mm of the turnpike tip remained in patients left circumflex artery.The patient was reported as fine post the procedure.".

• Brand Name: TURNPIKE SPIRAL 135CM
• 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: 22990305
• Report Number: 2134812-2025-00031
• Device Sequence Number: 15702524
• Product Code: DQY
• UDI-Device Identifier: 10841156100704
• UDI-Public: (01)10841156100704(11)250703(17)270703(10)73G2500055(21)
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• 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
• Report Date (Section B): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5640
• Device Lot Number: 73G2500055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2025
• 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