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	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found that would be associated to the reported event.Thus, the manufacturing records support that the device met material, assembly, and performance specifications prior to distribution.No product was received for evaluation.If the device returns, a follow up report will be submitted at the conclusion of the device evaluation.
Event or Problem Description
Chronic total occlusion on right coronary artery: catheter distal tip broken in calcification in rca (right coronary artery).A piece of the catheter remained stuck in the calcified part of the rca." clinical consequences : "no consequence for the patient but the coronary occlusion procedure failed."there was no patient injury.It does not matter that a piece is still in the patient because the piece is stuck in the "calcification" of the artery.Current patient condition reported as "fine" no patient injury or impact reported.
Additional Manufacturer Narrative
A manufacturing record was reviewed no nonconformances were found associated to this event, supporting the fact that the device met material, assembly, and performance specifications.The returned product evaluation confirmed the distal tip was separated.The distal tip was twisted which is consistent with over torqueing.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7726429
• Report Number: 2134812-2018-00048
• Device Sequence Number: 1452347
• Product Code: DQY
• UDI-Device Identifier: M20656420
• UDI-Public: M20656420
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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: 01/02/2020
• Device Model Number: 5642
• Device Lot Number: 618093
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR