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

Model Number 5639

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2023

Event Type  malfunction  

Event Description

It was reported that: a turnpike unravelled.Additional information on 11mar2023: during a cto of the rca procedure on the (b)(6) 2023, turnpike was used retrograde through the lad and septal to the rca.The turnpike lp unravelled at the shaft.Physician felt a lot of resistance while removing the turnpike.He was using it for about 10 mins over a guidewire.The turnpike lp was removed in its entirety and there was no material left in the vessel.A microcatheter was used in the procedure.The current patient condition is fine, and no patient harm was reported from this event.

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.

Manufacturer Narrative

(b)(4).One-unit of turnpike was returned to vsi/teleflex for evaluation.Blood particulates were noted on the unit.Severe torque and shaft damages were noted along the length of the turnpike.Unit was manufactured at tecate.A device history record review was completed.All processes were followed correctly.No nonconformities or rework was noted.Case details were reviewed.A patient underwent a procedure for cto of the rca.Turnpike was used retrograde through the lad and septal to the rca.Turnpike lp unravelled at the shaft.One unit of turnpike was returned.Sever shaft and torque damages were observed along the length of the shaft.The damages observed on the catheter are likely to have occurred during use in the procedure when operated against resistance.Per ifu 107585 rev a states the following warnings 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 additional information was requested.A response was received.Physician felt a lot of resistance while removing the turnpike.Turnpike was used over a guidewire.Tip was not trapped in the lesion.The number of rotations employed is unknown.No medical intervention was done.No material was left in the vessel.The turnpike was removed in its entirety.Asahi caravel was used to complete the procedure.Patient condition is fine.No harm noted.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 Description

It was reported that: a turnpike unravelled.Additional information on 11mar2023: during a cto of the rca procedure on the (b)(6) 2023, turnpike was used retrograde through the lad and septal to the rca.The turnpike lp unravelled at the shaft.Physician felt a lot of resistance while removing the turnpike.He was using it for about 10 mins over a guidewire.The turnpike lp was removed in its entirety and there was no material left in the vessel.A microcatheter was used in the procedure.The current patient condition is fine, and no patient harm was reported from this event.

• Brand Name: TURNPIKE LP
• Type of Device: 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16543779
• MDR Text Key: 311689323
• Report Number: 2134812-2023-00012
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10841156108748
• UDI-Public: 10841156108748
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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 Operator: 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
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1