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	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "distal tip of turnpike spiral 135cm catheter detached from the catheter shaft and lodged in calcium lesion of patient's rca.Tip could not be retrieved by physician, dr.(b)(6), and the broken off tip was trapped against vessel wall with a stent.Turnpike spiral was used with a 6f r4 guide and over a 300cm wire.Patient was discharged, stable per nurse; no calls or er visits post procedure and follow-up with dr in office is pending.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "distal tip of turnpike spiral 135cm catheter detached from the catheter shaft and lodged in calcium lesion of patient's rca.Tip could not be retrieved by physician, dr.(b)(6), and the broken off tip was trapped against vessel wall with a stent.Turnpike spiral was used with a 6f r4 guide and over a 300cm wire.Patient was discharged, stable per nurse; no calls or er visits post procedure and follow-up with dr in office is pending.".
Additional Manufacturer Narrative
(b)(4).The customer report of catheter tip damage was able to be confirmed through investigation of the returned sample.The customer returned one turnpike spiral and lidstock for evaluation.Visual analysis confirmed that the distal tip of the catheter had become separated.Significant damage was observed on the remaining portion of the catheter tip.Signs of use were observed.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user "never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury." additionally, "do not rotate the catheter more than two (2) consecutive 360 rotations in either direction if the distal tip becomes lodged and is not also rotating, as it may result in separation of the catheter, damage to the catheter, or vessel injury.".Based on the customer report and the returned sample, unintentional user error likely caused or contributed to the event.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 21933423
• Report Number: 2134812-2025-00019
• Device Sequence Number: 9031155
• Product Code: DQY
• UDI-Device Identifier: 10841156100704
• UDI-Public: (01)10841156100704(11)231215(17)251204(10)73M2300123(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 04/14/2025

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 Expiration Date: 12/04/2025
• Device Catalogue Number: 5640
• Device Lot Number: 73M2300123
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2023
• 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