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

Model Number	5643
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A returned product evaluation was completed.The turnpike shaft was broken right at the hub and there was severe torque damage.The turnpike ifu warns, "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 most likely root cause for the failure is damage during use.The submission of this mdr is part of a voluntary remedial action.
Event or Problem Description
Retrograde from vein graft to om to open native cx.Very calcified and the retrograde knuckle was wrapping around the vessel subintimal around the calcium.Mid cx it was in the lao view doing almost a 180 degree turn in a short segment.Got the turnpike up to the guidelines after lots of torque (both ways).Got turnpike into the guidelines (8 fr) but physician thought it was difficult to track into the gl.Eventually got in and delivered.When physician tried to take the turnpike out, it was stuck and would not come back.He ballooned down the side of the turnpike on an antegrade knuckle and this did not release the turnpike.Eventually he pulled the turnpike out of the antegrade micro catheter and then the turnpike came back through the tortuosity.This was a case of supreme tortuosity and calcium restricting the device.The angles looked severe.No patient impact was reported.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8252408
• Report Number: 2134812-2019-00004
• Device Sequence Number: 1929241
• Product Code: DQY
• UDI-Device Identifier: M20656430
• UDI-Public: M20656430
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/27/2017

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 Model Number: 5643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2017
• 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