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

Model Number	5640
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found therefore, supporting the device met material, assembly and performance specifications prior to shipment.The event details state the turnpike was used five times with fifteen spins each time in a tortuous lesion.It is likely that the tip of the turnpike was damaged during this interaction and eventually separated.
Event or Problem Description
Mid lad lesion with tortuosity.Turnpike spiral was used 5 times with 15 spins, both clockwise to advance, and counter-clockwise to remove.Tip of the micro-catheter broke off and was lodged in artery.Several hours were spent to retrieve tip but was unsuccessful.Patient was sent for bypass surgery.Patient is stable as of (b)(6) 2019.When we have further information, we will decide about releasing the catheter.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8805395
• Report Number: 2134812-2019-00049
• Device Sequence Number: 16223319
• Product Code: DQY
• UDI-Device Identifier: 10841156100704
• UDI-Public: 10841156100704
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 05/16/2021
• Device Model Number: 5640
• Device Lot Number: 649228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/18/2019
• 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