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

Model Number	5639
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found.A returned product evaluation was completed and confirmed that the hub was intact, and the shaft was broken at the proximal point of the strain relief.This damage is consistent with over torqueing the device in a heavily calcified lesion.The most likely root cause is damage during use.The submission of this mdr is part of a voluntary remedial action.
Event or Problem Description
Turnpike lp was deeply advanced in heavily calcified vessel, and with continued torqueing the hub separated and came off the catheter.No patient injury or impact was reported.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8252359
• Report Number: 2134812-2019-00003
• Device Sequence Number: 2195976
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: M20656390
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/12/2017

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: Health Professional
• Device Expiration Date: 03/29/2019
• Device Model Number: 5639
• Device Lot Number: 606537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1