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

Model Number 5640

Device Problems Difficult to Remove (1528); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2016

Event Type  malfunction  

Event Description

A turnpike spiral catheter was used during a patient procedure.During the procedure the turnpike got stuck on the guidewire and was not able to advance or withdraw.The turnpike and guidewire were removed together.No patient impact was reported.

• Brand Name: TURNPIKE SPIRAL
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: renee michael ; 6464 sycamore court north; maple grove, MN 55369 ; 7636564366
• MDR Report Key: 5780368
• MDR Text Key: 49127159
• Report Number: 2134812-2016-00047
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 5640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1