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

Model Number	5638
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found.There was no returned product to complete an evaluation on.Therefore, the root cause is undeterminable.If device returns a follow-up report will be issued.
Event or Problem Description
The tip of the turnpike broke down in the coronary while advancing.The tip was removed successfully with lasso catheter.Delay of procedure reported.
Additional Manufacturer Narrative
The returned product evaluation confirmed that the distal tip of the catheter was separated, however the tip remained on the guidewire.The guidewire and the catheter shaft showed severe damage that is consistent with over-rotating the device in a tortuous environment.A manufacturing record review was completed and zero non-conformances were found.The most likely root cause for the failure is that the catheter was damage during use.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7176220
• Report Number: 2134812-2018-00005
• Device Sequence Number: 63713
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: M20656380
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2017

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: 11/16/2019
• Device Model Number: 5638
• Device Lot Number: 616362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 02/07/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention