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

Model Number	5638
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	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation on 18jan2017 found the guidewire was stretched which is consistent with pulling forcefully.The distal section of the catheter was severely damaged and a 1 mm piece of the tip was separated but remained on the guidewire.Undetermined if all pieces are accounted for.
Event or Problem Description
Physician was using turnpike lp for a lad antegrade cto case.The lp would not advance past the lesion, when physician pulled out the turnpike lp, the tip of the catheter has sheared off.Turnpike was removed with wire.Additional information received 29nov2016: nothing was left in the body, and no retrieval method was necessary.No patient injury or impact reported.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6311752
• Report Number: 2134812-2017-00011
• Device Sequence Number: 11004876
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: +M20656380/$$3181007598953C
• 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,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2016

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: Physician
• Device Expiration Date: 10/07/2018
• Device Model Number: 5638
• Device Lot Number: 598953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/08/2017
• Patient Sequence Number: 1