MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TURNPIKE LP 150CM; CATHETER

Catalog Number	5639
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "microcatheter was advanced through cx then through epicardial for retrograde procedure in cto.After encountering some resistance and microcatheter showing some signs of fatigue, operator attempted to remove the device.Even with pull back and torquing, device was not removable.Operator used rotaburr to cut the device.Needs to know if device is mri compatible as they would like to run an mri on the patient.".
Additional Manufacturer Narrative
Qn# (b)(4).Correction to section d: udi number.The udi number has been corrected to (b)(4) in this report.
Event or Problem Description
It was reported that: "microcatheter was advanced through cx then through epicardial for retrograde procedure in cto.After encountering some resistance and microcatheter showing some signs of fatigue, operator attempted to remove the device.Even with pull back and torquing, device was not removable.Operator used rotaburr to cut the device.Needs to know if device is mri compatible as they would like to run an mri on the patient.".
Additional Manufacturer Narrative
Qn#(b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.A dhr review was completed lot: 73f2400323 and no issues or nonconformities were noted.Case details were reviewed.The additional information indicated that approximately 3 cm of turnpike lp was left in the vessel.The ifu states the following warning and precaution: never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by f luoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury do not rotate the catheter more than two (2) consecutive 360 rotations in either direction if the distal tip is not also rotating and advancing, as it may result in separation of the catheter, damage to the catheter, or vessel injury.Exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking.It is not known to what extent, degree, or rigor this device has seen use and handling.Based on the information, the most likely root cause of the issue is undeterminable.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that: "microcatheter was advanced through cx then through epicardial for retrograde procedure in cto.After encountering some resistance and microcatheter showing some signs of fatigue, operator attempted to remove the device.Even with pull back and torquing, device was not removable.Operator used rotaburr to cut the device.Needs to know if device is mri compatible as they would like to run an mri on the patient.".

• Brand Name: TURNPIKE LP 150CM
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20840668
• Report Number: 2134812-2024-00058
• Device Sequence Number: 3928273
• Product Code: DQY
• UDI-Device Identifier: 10841156110697
• UDI-Public: (01)10841156110697(11)240617(17)260614(10)73F2400323(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191560
• 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,Followup
• Report Date (Section B): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2026
• Device Catalogue Number: 5639
• Device Lot Number: 73F2400323
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/23/2025; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2024
• 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; NOT REPORTED
• Patient Sex: Unknown