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

Model Number	IPN927571
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "tp spiral was guided to the stenosis under imaging.During imaging, dr noticed that the tip broke off.The tip was trapped in the lesion.Dr inserted another microcatheter over the tp spiral and was able to remove everything, including the guide wire and tp spiral.A stent was inserted.The patient was reported as fine post the procedure.".
Event or Problem Description
It was reported that: "tp spiral was guided to the stenosis under imaging.During imaging, dr noticed that the tip broke off.The tip was trapped in the lesion.Dr inserted another microcatheter over the tp spiral and was able to remove everything, including the guide wire and tp spiral.A stent was inserted.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of the turnpike tip separating was able to be confirmed through inspection of the customer supplied photos and the returned device.The customer provided four photos and returned one turnpike spiral 135cm (5640) for analysis.Signs of use were noted.Visual analysis of the returned sample revealed the distal tip of the catheter was severely damaged.The ptfe liner and metal braid could be seen protruding from the distal portion of the tip.Minor kinking was also noted along the catheter body.A device history record review was performed, and no relevant findings were identified.Additional information indicated that the tip of the turnpike was trapped in a lesion.It was reported that the device was used in accordance with the ifu in regard to trapping the tip and number of turns.The device was removed completely, and a stent was inserted.Based on the customer report and returned device, the probable cause is likely unintended use error.

• 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: 23252463
• Report Number: 2134812-2025-00037
• Device Sequence Number: 10252185
• Product Code: DQY
• UDI-Device Identifier: 10841156100704
• UDI-Public: (01)10841156100704(11)250215(17)270205(10)73B2500086(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/15/2025

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: 73B2500086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2025
• 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