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

Model Number 5642

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2015

Event Type  malfunction  

Event Description

A turnpike catheter was used during a patient procedure.When the turnpike was removed from the patient, a crack was observed in the hub of the turnpike.No patient impact was reported.

• Brand Name: TURNPIKE CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; maple grove MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; maple grove MN 55369
• Manufacturer Contact: renee michael ; 6464 sycamore court north; maple grove, MN 55369 ; 7636564366
• MDR Report Key: 5318736
• MDR Text Key: 34136392
• Report Number: 2134812-2015-00044
• 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,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: 5642
• Device Lot Number: 584725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1