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

Model Number 5640

Device Problem Separation Problem (4043)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.

Event Description

As reported: physician used a turnpike spiral and during the procedure a piece of the black tip separated from the end and was in the left main.They were unable to retrieve using a snare, so they placed a stent in the left main to keep the piece of the tip in place against the wall of the artery.

Manufacturer Narrative

Turnpike was returned to vsi/teleflex for evaluation.Lot: 704744 was reviewed.There are no non-conformances related to this lot therefore supporting the device met material, assembly and performance specifications.Additional information was requested form the account.No response was received.Only an image of the turnpike was sent confirming damages to the tip.The tip was unable to be snared out of the vessel.A stent was placed in the left main to keep the piece of the tip in place against the wall of the artery.No blood particulates were noted on the shaft.The tip of the catheter was severely damaged, torqued, and fatigued.Approximately 0.2 cm of tip material was observed to be sheared off from the distal section of the tip.The shaft of the catheter had a minor kink.Length, o.D., o.D at the distal section, were measured and catheter met specification per drawing.No other damages were noted.

• Brand Name: TURNPIKE SPIRAL
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11638248
• MDR Text Key: 246969983
• Report Number: 2134812-2021-00027
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20841156105089
• UDI-Public: (01)20841156105089
• Combination Product (y/n): N
• PMA/PMN Number: K191560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: 5640
• Device Lot Number: 704744
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention