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

Model Number 135CM

Device Problem Material Fragmentation (1261)

Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Date 06/15/2016

Event Type  Injury  

Event Description

While attempting to cross the subtotal occlusion in the distal lad, the end of a turn pike catheter broke off within the occlusion.This resulted in obstruction to flow through the distal lad but could not be retrieved.

• Brand Name: TURNPIKE
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC. ; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 5771886
• MDR Text Key: 48859822
• Report Number: MW5063232
• Device Sequence Number: 1
• Product Code: DQY
• 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: 06/30/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2017
• Device Model Number: 135CM
• Device Catalogue Number: 5642
• Device Lot Number: 587787
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 73