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	12/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for investigation.The strain relief was removed to visual the section of separation; it shows the separation of the shaft at the hub.The root cause is determined to be excessive torque applied during the procedure.The turnpike ifu states "do not rotate the catheter more than two (2) consecutive 360° rotations in either direction if the distal tip becomes lodged and is not also rotating, as it may result in separation of the catheter, damage to the catheter, or vessel injury.The submission of this mdr is part of a voluntary remedial action.
Event or Problem Description
During a cto case the hub cracked off the catheter.The turnpike catheter was used in a cto case and after some time, the hub fatigued and cracked off the catheter.Had to retract it out of the body and switched to a different catheter.No adverse patient outcomes or impact were noted.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8252577
• Report Number: 2134812-2019-00006
• Device Sequence Number: 13848793
• 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): 12/12/2016

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: Health Professional
• Device Expiration Date: 10/25/2018
• Device Model Number: 5639
• Device Lot Number: 599766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2016
• 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