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

Model Number	5640
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11638248
• Report Number: 2134812-2021-00027
• Device Sequence Number: 14366794
• Product Code: DQY
• UDI-Device Identifier: 20841156105089
• UDI-Public: (01)20841156105089
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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: 12/14/2022
• Device Model Number: 5640
• Device Lot Number: 704744
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention