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

Catalog Number	5641
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the tip of the turnpike broke off.The case was completed with a different device.The patient was reported as fine.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).No return product evaluation could be completed as the device was not returned for investigation.A dhr review was completed for lot 73h2300033, and no issues or nonconformities were noted.Case details were reviewed.It is unknown to what extent and degree of damages were present on the unit.It is unknown how much of tip separation occurred.It is unknown if the tip was torqued against resistance.The ifu states the following: - 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 a manufacturing record review was completed for lot 73h2300033 and no related nonconformances were found.Based on the limited information and no product evaluation, the most likely root cause of the issue is undeterminable.The der process will continue to monitor for any similar events.Corrected data: correction to section d.4.Udi was updated from (b)(4) to (b)(4) to include the full udi.
Event or Problem Description
It was reported that: "the tip of the turnpike broke off.The case was completed with a different device.The patient was reported as fine.".

• Brand Name: TURNPIKE SPIRAL 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: 19390653
• Report Number: 2134812-2024-00023
• Device Sequence Number: 20773984
• Product Code: DQY
• UDI-Device Identifier: 10841156100711
• UDI-Public: 10841156100711
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/01/2025
• Device Catalogue Number: 5641
• Device Lot Number: 73H2300033
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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
• Patient Sex: Unknown