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

Model Number	IPN927572
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during a pci to treat in-stent restenosis.This is in-stent restenosis.Therefore, predilation with a non-compliant balloon followed by drug-coated balloon.Due to distal perforation, it was necessary to embolize the leak with coils.The first microcatheter was unable to pass through the first old stent.This is why we used the turnpike instead.At the same location, the turnpike became stuck and would not advance any further.After two clockwise turns, it still would not advance.We decided to remove the microcatheter and predilate this section where the microcatheters was stuck.When we removed the turnpike, the distal tip detached and remained stuck in the old stent.Subsequently, jailing of the broken tip with a new stent.Took a new microcatheter and embolization of 4x coils to occlude the perforation.It took some time to jail the lost tip, but once it was done, the patient was able to leave the clinic 48 hours later with no sequelae related to the lost tip.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Additional information indicated that the vessel location was the bisecting artery or intermediate branch, and the procedure was in-stent restenosis in the middle segment.The artery was neither tortuous nor calcified.The approach was antegrade.The first microcatheter used (corsair pro) was unable to pass through the first old stent.A turnpike was used and became stuck at the same location.After two clockwise turns, it would still not advance.When the turnpike was removed, the distal tip detached and remained stuck in the middle segment of the old stent.The tip was jailed, and patient was able to leave with no sequela related to the lost tip.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "during a pci to treat in-stent restenosis.This is in-stent restenosis.Therefore, predilation with a non-compliant balloon followed by drug-coated balloon.Due to distal perforation, it was necessary to embolize the leak with coils.The first microcatheter was unable to pass through the first old stent.This is why we used the turnpike instead.At the same location, the turnpike became stuck and would not advance any further.After two clockwise turns, it still would not advance.We decided to remove the microcatheter and predilate this section where the microcatheters was stuck.When we removed the turnpike, the distal tip detached and remained stuck in the old stent.Subsequently, jailing of the broken tip with a new stent.Took a new microcatheter and embolization of 4x coils to occlude the perforation.It took some time to jail the lost tip, but once it was done, the patient was able to leave the clinic 48 hours later with no sequelae related to the lost tip.".

• Brand Name: TURNPIKE SPIRAL 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 23165674
• Report Number: 2134812-2025-00033
• Device Sequence Number: 8844934
• Product Code: DQY
• UDI-Device Identifier: 10841156100711
• UDI-Public: (01)10841156100711(11)241115(17)261115(10)73L2400459(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/01/2025

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: IPN927572
• Device Catalogue Number: 5641
• Device Lot Number: 73L2400459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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