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

Model Number	5643
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being based on the visual investigation and condition of the returned sample.The turnpike was returned along with the wire.The turnpike was not stuck on the wire and the distal tip of the turnpike was separated.The separated piece was still on the wire.The distal section of the catheter also showed damage consistent with over torquing against resistance.
Event or Problem Description
Calcified lesion where only wire would pass.Dr.Inserted 150cm regular turnpike and torqued catheter clockwise and counter clockwise while pushing catheter forward.The turnpike did not cross the lesion.Dr.Decided to take out regular turnpike and try turnpike gold.Upon withdrawing turnpike it wouldn't move on the wire.It was determined it was stuck and turnpike along with the wire were both removed.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7441195
• Report Number: 2134812-2018-00024
• Device Sequence Number: 16528989
• Product Code: DQY
• UDI-Device Identifier: M20656430
• UDI-Public: M20656430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2017

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: Physician
• Device Expiration Date: 04/28/2018
• Device Model Number: 5643
• Device Lot Number: 594001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 04/18/2018
• Patient Sequence Number: 1