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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the customer returned one turnpike spiral for evaluation.Signs of use were observed.Visual analysis revealed significant damage to the distal tip of the catheter.The proximal portion of the tip was separated from the body of the catheter.Portions of the ptfe liner and metal braid were visible.Twists and deformations were also visible at both ends of the separation.A minor kink was also observed on the catheter body.No defects or anomalies were observed on any other potion of the returned device.The customer report of catheter tip damage or separation was able to be confirmed through investigation of the returned sample.Visual analysis confirmed that the distal tip of the catheter had become separated.Significant damage was observed on the distal tip of the main catheter body and the proximal end of the separated tip piece.A device history record review was performed, and no relevant findings were identified.Additional information was received.The vessel was heavily calcified, and the turnpike tip was trapped in a lesion.The physician stated the device was "overclocked" and torqued excessively and does not believe it to be a product failure.The broken tip of the turnpike was retrieved from the patient using a trapliner and a balloon.Based on the information received and the returned sample, user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "broken in a vessel and took an hour to retrieve." additional information: "physician admitted to "overclocking" and stated that he doesn't believe it was a product failure.Trapliner and a balloon were used to maneuver and retrieve the broken tip of the turnpike spiral.".

• 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: 22573795
• Report Number: 2134812-2025-00027
• Device Sequence Number: 9576815
• Product Code: DQY
• UDI-Device Identifier: 10841156100704
• UDI-Public: (01)10841156100704(11)250326(17)270316(10)73C2500344(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/30/2025

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: 5640
• Device Lot Number: 73C2500344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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