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

Model Number	5638
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
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 unable to be completed, as no devices were returned to vsi.If device returns for evaluation, and further information is obtained, a follow-up report will be reported.
Event or Problem Description
As the cardiologist was doing the procedure he came across severe calcification present with bifurcation and attempted to pass with several balloons after using a guide and crossing the lesion with a luge wire via the radial artery, cardiologist obtained access of the right femoral artery and able to re-wire with 8 french guide, the turnpike lp then fractured and plugged the vessel resulting in cessation of flow and could not remove the wire as it was fixed and once that was clear did not want to lose wire position.St segments elevated and then able to pass 1.2 mm balloon through the lesion and it pushed the tip of the catheter downstream, balloon inflated and the turnpike was advanced and the rota wire was exchanged.Pt did receive stents.The patient is reported as doing fine.Patient discharged to home (b)(6) 2018.Initial information received via medwatch 5078186 on july 09, 2018.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7761803
• Report Number: 2134812-2018-00049
• Device Sequence Number: 1230916
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: M20656380
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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: 5638
• Device Lot Number: 622384
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 08/08/2018
• 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
• Patient Age: 69 YR
• Patient Weight: 74