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

Model Number	5640
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances related to this failure were found.The returned product evaluation confirmed the distal tip of the catheter was separated.The separated piece was still on the guidewire.The tip of the turnpike was twisted and "sanding" marks were present.The ptfe inner layer was exposed and twisted.Based on the evidence found and the event description the most likely root cause for this failure is advancing/withdrawing/torquing against resistance.
Event or Problem Description
Dr.Had a very calcified torturous rca.The wire went down fine and once he started to deliver the tp he said it was advancing no problem.Once he saw he was in the tortuous vessel it stopped tracking and nothing he did would release it.The tip also appeared off the catheter.He eventually put a 3mm stent with a second wire and then pulled everything out with great effort.The tip was not attached to the catheter.I believe it was separated but pulled out with the wire.Dr.Then was able to finish the case with additional stent and balloon.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7359709
• Report Number: 2134812-2018-00012
• Device Sequence Number: 1103549
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/20/2018

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: Physician
• Device Expiration Date: 12/07/2019
• Device Model Number: 5640
• Device Lot Number: 616882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention