MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TURNPIKE SPIRAL; CATHETER

Model Number	5639
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "manager got a message regarding the tip breaking off a turnpike.Tried reaching out to cath lab manager device currently going through the hospital investigation process." additional information on 07mar2023: during a cardiac catheterization on the (b)(6) 2023, the turnpike tip got stuck on the side of a stent.The operator was able to place an additional stent to crush the fractured tip to the wall of the artery.The patient did recover and is in good condition.The patient's current condition is doing well post procedure.
Additional Manufacturer Narrative
Qn# (b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after investigation.
Additional Manufacturer Narrative
(b)(4).One-unit of turnpike was returned to vsi/teleflex for evaluation.Blood particulates were noted on the unit.Tip of the turnpike was damaged and fatigued exposing the liner material.Approximately 0.4 cm of tip material was observed to be missing.Unit was manufactured at tecate.A device history record review was completed.All processes were followed correctly.No nonconformities noted.Case details were reviewed.A patient underwent a procedure in which a turnpike lp was used.Customer stated that the tip of the turnpike broke off.One-unit of turnpike was returned to vsi/teleflex for evaluation.Blood particulates were noted on the unit.Tip of the turnpike was damaged and fatigued exposing the liner material.Approximately 0.4 cm of tip material was observed to be missing.Damages are likely to have occurred during use in the procedure when operated against resistance.Per ifu 107585 rev a, 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 additional information was requested.A response was received.The turnpike got stuck on the side of a stent.The operator was able to place an additional stent to crush the fractured tip to the wall of the artery.No angiograms were shared.Vessel and anatomical conditions are unknown.Patient recovered and is in good condition.Tip fatigue and separation is likely due to the tip interaction with the side of stent.A manufacturing record review was completed by tecate 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.
Event or Problem Description
It was reported that: "manager got a message regarding the tip breaking off a turnpike.Tried reaching out to cath lab manager device currently going through the hospital investigation process." additional information on 07mar2023: during a cardiac catheterization on the (b)(6) 2023, the turnpike tip got stuck on the side of a stent.The operator was able to place an additional stent to crush the fractured tip to the wall of the artery.The patient did recover and is in good condition.The patient's current condition is doing well post procedure.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16511359
• Report Number: 2134812-2023-00008
• Device Sequence Number: 5849218
• Product Code: DQY
• UDI-Device Identifier: 10841156108748
• UDI-Public: 10841156108748
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 05/31/2024
• Device Model Number: 5639
• Device Catalogue Number: 5639
• Device Lot Number: 73E2201173
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown