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

Model Number	5642
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found, therefore supporting the device met material, assembly and performance specifications.A returned product evaluation was completed and the failure was confirmed.The distal tip of the turnpike was separated and remained on the wire.The damage found the distal section of the turnpike is consistent with over torqueing the catheter against resistance.
Event or Problem Description
During a heavily calcified lesion in the lad, a turnpike catheter was used to facilitate wire exchange.A wire was advance passed the lesion and the turnpike was loaded on the wire but was unable to be spun passed the lesion.When the turnpike was removed, it was noticed that there was something still on the wire.A second wire was placed down the vessel and the original wire was removed with the material still attached.The case was completed with good results using rotablator.Additional information received via phone call received which reported the tip detached, however, stayed on wire.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7913832
• Report Number: 2134812-2018-00066
• Device Sequence Number: 16336154
• Product Code: DQY
• UDI-Device Identifier: M20656420
• UDI-Public: M20656420
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/29/2018

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: 03/21/2020
• Device Model Number: 5642
• Device Lot Number: 622204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR