MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC ARROW TURNPIKE SPIRAL 135CM; CATHETER, PERCUTANEOUS

Catalog Number	5640
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: tip of catheter disengaged with the shaft whilst in the coronary artery.Additional information: the device was removed, and the procedure continued.The procedure was ultimately successful.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).One-unit of turnpike was returned for evaluation.Blood particulates were noted on the unit.Unit was decontaminated and inspected.Approximately 6 mm of tip separation was confirmed.The remaining tip material left on the shaft was observed to be fatigued and twisted.A dhr review was completed for lot 73d2300884 and no issues or nonconformities were noted.Case details were reviewed.The device evaluation confirmed approximately 6 mm of tip separation.The remaining tip material left on the shaft was observed to be fatigued and twisted.Damages are likely to have occurred during use in the procedure.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.Exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking.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.As per the additional information received, no medical intervention was performed.Device was removed and the procedure was continued.It is unclear how the separated tip was managed or removed from the vessel.Damages incurred by the turnpike is likely due to operation against resistance against a calcified lesion.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 operational context and/or unintended use error.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that: tip of catheter disengaged with the shaft whilst in the coronary artery.Additional information: the device was removed, and the procedure continued.The procedure was ultimately successful.

• Brand Name: ARROW TURNPIKE SPIRAL 135CM
• 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: 18433758
• Report Number: 2134812-2023-00060
• Device Sequence Number: 15398873
• Product Code: DQY
• UDI-Device Identifier: 10841156100704
• UDI-Public: 10841156100704
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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 Expiration Date: 04/25/2025
• Device Catalogue Number: 5640
• Device Lot Number: 73D2300884
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/06/2024
• 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.
• Patient Sex: Unknown