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 Code	Foreign Body In Patient (2687)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "i was retrograde through a septal collateral into the distal rca.The turnpike stalled.I tried to remove the catheter and realized the shaft had broken approximately 12cm from the tip.I was able to retrieve the broken device.No harm came to the patient.The broken device was sent to supply to escalate the incident." additional information: "turnpike stalled it wasn't stuck.I was retrograde through a lad septal into distal rca with tp.Pilot 200 wire knuckled through tp into mid rca.Shaft separated about 12cm from tip.I was able to trap the distal shaft with a balloon in a guidliner passed on a separate wire.".
Event or Problem Description
It was reported that: "i was retrograde through a septal collateral into the distal rca.The turnpike stalled.I tried to remove the catheter and realized the shaft had broken approximately 12cm from the tip.I was able to retrieve the broken device.No harm came to the patient.The broken device was sent to supply to escalate the incident." additional information: "turnpike stalled it wasn't stuck.I was retrograde through a lad septal into distal rca with tp.Pilot 200 wire knuckled through tp into mid rca.Shaft separated about 12cm from tip.I was able to trap the distal shaft with a balloon in a guidliner passed on a separate wire.".
Additional Manufacturer Narrative
(b)(4).One-unit of turnpike was returned to teleflex for evaluation in two pieces.Blood particulates were noted on the unit.Unit was decontaminated and inspected.1st piece measurement (shaft to distal tip): 11.6 cm.2nd piece measurement (shaft to shaft distal - point of separation): 130.5 cm.Severe shaft damages were observed along the length of the shaft for piece 1.Damages include excess torque damage, kinks, and coil damages.Turnpike was locked onto the guidewire.A dhr review was completed for lot 73b2401018, and no issues or nonconformities were noted.Case details were reviewed.Damages are likely to have occurred during use in the procedure when torqued against resistance.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.Additional information was requested.A response was received.Turnpike was used in a retrograde case from lad septal to distal rca.Pilot wire knuckled through turnpike into mid rca.Shaft separated.The distal shaft was trapped with a balloon in the guideliner.The piece was removed.Small septal perforation was noted but inconsequential.Procedure was successful.Patient is well.Based on product evaluation, excessive torquing would lead to severe shaft damages and/or separation.A manufacturing record review was completed and no related nonconformances were found.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.

• 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: 19952563
• Report Number: 2134812-2024-00034
• Device Sequence Number: 8966890
• Product Code: DQY
• UDI-Device Identifier: 10841156100698
• UDI-Public: (01)10841156100698(11)240227(17)260227(10)73B2401018(21)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/12/2024

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: 02/27/2026
• Device Catalogue Number: 5639
• Device Lot Number: 73B2401018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Unknown