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

Catalog Number	5639
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "turnpike lp was used in the hospital in zwolle the netherlands on 7 february 2024 during a cto.During retracting after spinning the device in a coronary artery (intended use by experienced operator) the turnpike lp broke down in 2 pieces.Catheter fracture at 20 cm from the distal tip.Catheter was retracted, fractured piece was retracted with snaring technique ( en snare from merit medical).After asking: no negative effect on patient or outcome, but procedure lasted longer." additional information: turnpike lp was used in retrograde case, from lad to rca via septal channel.It broke after extensive torqueing and pushing in a very difficult case.It was cut "clean" during a 90 degree bend where there was extensive calcium under and above the bend of 90 degrees from lad to septal.Both doctors also noted multiple scratches on the turnpike proximal of the turnpike lp leisure.Patient had two previous events with broken material from a different supplier in previous cases in the right arm and one in the rca.When the turnpike broke doctors felt no resistance and took out proximal part, but only measured 130 cm.Distal 20 cm was retrieved by using a snare, which was positioned over the turnpike lp.A balloon catheter was inserted in the snare as well to trap the turnpike lp.All devices were removed all at once.Procedure was discontinued, cto remained as it was.There was a small septal dissection, which closed spontaneously.Patient had no negative effects and did not need special care.
Additional Manufacturer Narrative
Qn#(b)(4).One-unit of turnpike was returned for evaluation in two pieces without the presence hub.Blood particulates were noted on the unit.Unit was decontaminated and inspected.Severe shaft damages were observed along the length of the shaft for piece 1.Damages include excess torque damage, crimped shaft, kinks, and coil damages.Turnpike was locked onto the guidewire.Distal piece 2 was damaged.The shaft material was twisted with liner exposed.Damages are likely to have occurred during use in the procedure when torqued against resistance.A dhr review was completed for lot 73e2300064.No issues or nonconformities were noted.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 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.As per the additional information received, turnpike was used in a retrograde case from lad to rca via septal channel.The turnpike broke due to extensive torquing.The shaft was cut during a 90-degree bend due to the presence of extensive calcium under and above the 90-degree bend from lad to septal.The turnpike was trapped within the guidewire with a balloon catheter.All the units were removed together.Procedure was discontinued.A small septal dissection was noted which closed spontaneously.No negative effects noted on the patient.Based on product evaluation, excessive torquing would lead to severe shaft damages and/or separation.Based on the information, the most likely root cause of the issue is user error.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that "turnpike lp was used in the hospital in (b)(6) on (b)(6) 2024 during a cto.During retracting after spinning the device in a coronary artery (intended use by experienced operator) the turnpike lp broke down in 2 pieces.Catheter fracture at 20 cm from the distal tip.Catheter was retracted, fractured piece was retracted with snaring technique ( en snare from merit medical).After asking: no negative effect on patient or outcome, but procedure lasted longer." additional information: turnpike lp was used in retrograde case, from lad to rca via septal channel.It broke after extensive torqueing and pushing in a very difficult case.It was cut "clean" during a 90 degree bend where there was extensive calcium under and above the bend of 90 degrees from lad to septal.Both doctors also noted multiple scratches on the turnpike proximal of the turnpike lp leisure.Patient had two previous events with broken material from a different supplier in previous cases in the right arm and one in the rca.When the turnpike broke doctors felt no resistance and took out proximal part, but only measured 130 cm.Distal 20 cm was retrieved by using a snare, which was positioned over the turnpike lp.A balloon catheter was inserted in the snare as well to trap the turnpike lp.All devices were removed all at once.Procedure was discontinued, cto remained as it was.There was a small septal dissection, which closed spontaneously.Patient had no negative effects and did not need special care.

• 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: 18864598
• Report Number: 2134812-2024-00007
• Device Sequence Number: 11594616
• Product Code: DQY
• UDI-Device Identifier: 10841156100698
• UDI-Public: 10841156100698
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K151981
• 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): 02/12/2024

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: 05/02/2025
• Device Catalogue Number: 5639
• Device Lot Number: 73E2300064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown