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

Model Number	5642
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed and confirmed the complaint received.The distal tip of the turnpike was damaged, and material was separated.The separated material was caught in the coils of the guidewire that was also returned.There was no other damage to the catheter.
Event or Problem Description
As reported: the customer had smooth 135cm turnpike over a wire and engaged in calcium, torqueing the device, and part of the tip broke off on the wire.Broken tip was able to be retrieved as the unit was on a wire.The case was completed successfully as the broken unit was fully retrieved, and customer used a turnpike gold to finish case.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9596410
• Report Number: 2134812-2020-00003
• Device Sequence Number: 2436717
• Product Code: DQY
• UDI-Device Identifier: 10841156100728
• UDI-Public: (01)10841156100728
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/19/2019

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: Health Professional
• Device Expiration Date: 11/14/2021
• Device Model Number: 5642
• Device Catalogue Number: 5642
• Device Lot Number: 662505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention