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

Model Number	IPN927571
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "tp spiral used with a guidewire in a cto / complex case - so arteries needed some work.Dr suspected there was an issue with the hub.The guidewire got stuck and could not be moved forward through the microcatheter.The dr tried to move it, but it led to a perforation.Patient is fine.Dr not sure whether the tp spiral was the issue but wanted to investigate.".
Additional Manufacturer Narrative
(b)(4).The customer report of a stuck guidewire was unable to be confirmed through investigation of the returned sample.The customer returned one turnpike spiral (5640) for analysis.Visual analysis revealed no defects or anomalies were present on the device.Functional testing was successful, and the returned catheter passed over a guidewire without resistance.Some blood was noticed in the hub after passing the guidewire through the device.It is unknown if this blood could have caused the guidewire to get stuck during the case.A device history record review was performed, and no relevant findings were identified.Additional information indicated that the patient condition was fine and there were no health consequences.This was a chronic total occlusion (cto)/complex case.The turnpike spiral was removed, and other means were used to stabilize the patient.It is unknown what was used after the turnpike was removed.Based on the customer report and the sample received, no problem was found with the returned sample.
Event or Problem Description
It was reported that "tp spiral used with a guidewire in a cto/complex case - so arteries needed some work.Dr suspected there was an issue with the hub.The guidewire got stuck and could not be moved forward through the microcatheter.The dr tried to move it, but it led to a perforation.Patient is fine.Dr not sure whether the tp spiral was the issue but wanted to investigate.".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23704268
• Report Number: 2134812-2025-00048
• Device Sequence Number: 16132510
• Product Code: DQY
• UDI-Device Identifier: 10841156103927
• UDI-Public: (01)10841156103927(11)250622(17)270612(10)73F2500374(21)
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: IPN927571
• Device Catalogue Number: 5640
• Device Lot Number: 73F2500374
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2025
• 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
• Patient Sex: Unknown