MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TURNPIKE GOLD 135CM; CATHETER

Catalog Number	5621
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: the tip of the catheter became stuck in the coronary artery and had to be removed.This resulted in an extended procedure with limiting blood flow to the downstream circulation of the circumflex artery for the time of entrapment.Blood flow was restored with removal of the device and the patient was admitted to icu for observation.
Event or Problem Description
It was reported that: the tip of the catheter became stuck in the coronary artery and had to be removed.This resulted in an extended procedure with limiting blood flow to the downstream circulation of the circumflex artery for the time of entrapment.Blood flow was restored with removal of the device and the patient was admitted to icu for observation.
Additional Manufacturer Narrative
Qn# (b)(4).No returned product evaluation could be completed as the product was not returned for investigation.The top-level assembly traveller ((b)(6), lot 714806) was reviewed.There are no dda's, nce's or any other nonconformances related to this lot therefore supporting the device met material, assembly, and performance specifications.Case details were reviewed.Customer stated "i would like to report a product complaint involving the turnpike gold.The tip of the catheter became stuck in the coronary artery and had to be removed exhaustive effort all the while coordinating surgical backup.This resulted in an extended procedure with limiting blood flow to the downstream circulation of the circumflex artery for the time of entrapment.Blood flow was restored with removal of the device and the patient was admitted to icu for observation."no unit was returned to teleflex for evaluation.It is unknown what type of damages were incurred on the unit.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 unclear if any separation of the tip or shaft was noted.The complaint report stated that residual dissection was noted without a need for further intervention.Vessel dissection is a potential adverse effect identified with use of turnpike catheter.A manufacturing record review was completed and no related nonconformances were found.Based on the limited information, the most likely root cause of the issue is undeterminable.The der process will continue to monitor for any similar events.
Additional Manufacturer Narrative
Qn#(b)(4).In section d provided the full udi # **udi related data quality updates only**.
Event or Problem Description
It was reported that: the tip of the catheter became stuck in the coronary artery and had to be removed.This resulted in an extended procedure with limiting blood flow to the downstream circulation of the circumflex artery for the time of entrapment.Blood flow was restored with removal of the device and the patient was admitted to icu for observation.

• Brand Name: TURNPIKE GOLD 135CM
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18254459
• Report Number: 2134812-2023-00056
• Device Sequence Number: 6572168
• Product Code: DQY
• UDI-Device Identifier: 10841156105105
• UDI-Public: (01)10841156105105(11)211214(17)231128(10)714806(21)
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2023

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 Catalogue Number: 5621
• Device Lot Number: 1084115610
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 11/08/2023; Not provided
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/16/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 60 YR
• Patient Sex: Male