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

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	01/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: dr.Was performing a lm, lcx cto.He was using the turnpike lp retrograde over a mongo wire to the mid-lcx and he said it fatigued and he tried to remove it over the mongo wire and it would budge, it was stuck around the bendy part of the lcx, he tried to walk it out and nothing moved.He tried to tug on it and nothing moved, he tried to exchange the wire for another mongo and that did not help with backing out the system he added an extension wire to the mongo wire and then lost the wire, so he had to cut the turnpike to find the wire to remove it.He is estimating 15cm of catheter has been left in the patient's vessel , but he did not perf the vessel nor did it cause an mi.Patient was reported as fine.
Additional Manufacturer Narrative
Qn # (b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).One-unit of turnpike (split into two pieces) was returned to teleflex for evaluation.Blood particulates were noted on the unit.Unit was decontaminated and inspected.The following was noted piece 1: the working length measured approximately 46 cm from hub.The shaft was crimped at the separated junction.Piece 2: from the point of separation at 46 cm, the length of the shaft measures 84.5 cm.Severe twist of the coil and lumen was noted.Liner material was exposed.Approximately 19.5 cm of the shaft was missing.A dhr review was conducted for lot 73a2300263.All processes were followed correctly.No issue or nonconformities were noted.Case details were reviewed.One unit of turnpike (split as two pieces) was returned to teleflex for evaluation.Together both the pieces measured 130.5 cm.Approximately 19.5 cm of the distal shaft was missing.Distal end of the turnpike was observed to be severely twisted with liner exposed.Additional information was received with fluoroscopic images which show the use of turnpike lodged in the vessel.Per customer, no perforation or mi was caused due to this event.The following warning and precautions were noted in the ifu.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.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.Based on the product evaluation, the distal end of the turnpike was subjected to severe torque.This indicates that tension was built at this junction when operated against resistance with the catheter in the anatomy.The most likely root cause of the issue is operational context and/or user error.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that: dr.Was performing a lm, lcx cto.He was using the turnpike lp retrograde over a mongo wire to the mid-lcx and he said it fatigued and he tried to remove it over the mongo wire and it would budge, it was stuck around the bendy part of the lcx, he tried to walk it out and nothing moved.He tried to tug on it and nothing moved, he tried to exchange the wire for another mongo and that did not help with backing out the system he added an extension wire to the mongo wire and then lost the wire, so he had to cut the turnpike to find the wire to remove it.He is estimating 15cm of catheter has been left in the patient's vessel , but he did not perf the vessel nor did it cause an mi.Patient was reported as fine.

• Brand Name: TURNPIKE LP 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 MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18694516
• Report Number: 2134812-2024-00004
• Device Sequence Number: 18270034
• Product Code: DQY
• UDI-Device Identifier: 10841156100698
• UDI-Public: 10841156100698
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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: 01/09/2025
• Device Catalogue Number: 5639
• Device Lot Number: 73A2300263
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown