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

Catalog Number 5638

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 06/14/2018

Event Type  Injury  

Event Description

High complex lesion with severe calcification with present bifurcation.Unable to get turnpike lp to cross, the lp tip fractured and plugged the vessel resulting in cessation of flow, not able to remove.St segments elevated; 1.2 mm balloon able to push through the lesion that pushed the tip of the catheter downstream, after turnpike advanced and the rota wire was exchanged.Several stents were deployed to cover the lesion in its entirety and final angiograms with at timi flow of 3.Pt to cardiovascular icu on a iabp and discontinued the following day and able to recover and able to discharge on day two.

• Brand Name: TURNPIKE LP CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC. ; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7654495
• MDR Text Key: 113040678
• Report Number: MW5078186
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2020
• Device Catalogue Number: 5638
• Device Lot Number: 622384
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 74