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

Model Number	5640
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and zero related nonconformances were found.A returned product evaluation was also completed and found the device to be severely damaged.Torque damage was present along the distal section of the device and the tip was confirmed missing.The ptfe liner was exposed and twisted.The physician confirmed resistance was experienced when advancing the device due to the difficulty crossing the proximal cap of the lesion.Based on this information and the torque damage present, the product meets the design and manufacture specification but was damaged during use due to the operational context.
Event or Problem Description
The physician reported that the device was unable to cross the lesion and when he removed the device noted that the tip was damaged and a little part of it remained stuck in the lesion.Additional info rec'd (b)(6) 2018: the physician reported that he encountered resistance in advancing the turnpike spiral because the proximal cap of the lesion was hard to cross; no resistance in advancing the microcatheter on the guidewire until the proximal cap of the lesion.The physician used a guide catheter extension (guideliner) and two different guidewires.The physician did not try to remove the "little part" from the lesion.The procedure was not completed because it was not possible to cross the lesion.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8232609
• Report Number: 2134812-2019-00001
• Device Sequence Number: 215243
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/11/2018

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: 08/22/2020
• Device Model Number: 5640
• Device Lot Number: 631956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1