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

Model Number	5640
Medical Device Problem Codes	Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of returned device on 17jan17 found turnpike catheter showed signs of biological contamination.The distal section of the catheter was severely damaged and fragments of the tungsten tip separated and were caught on the guidewire.The distal tip was twisted and the ptfe inner layer was exposed.The distal nylon coil was intact.Fragments of the tungsten tip was caught on the guidewire and tip is twisted and shows damage consistent with over-rotating against resistance.Fragments of the tungsten tip are missing.Undetermined if all pieces are accounted for.
Event or Problem Description
The supply manager reported that the tip of the turnpike spiral came off on the guidewire.There was no patient impact or injury reported.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6313766
• Report Number: 2134812-2017-00014
• Device Sequence Number: 659111
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: +M20656400/$$31808225976726
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142065
• 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): 11/15/2016

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
• Operator of Device: No Information
• Device Expiration Date: 08/22/2018
• Device Model Number: 5640
• Device Lot Number: 597672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 02/09/2017
• Patient Sequence Number: 1