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

Model Number 5640

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2015

Event Type  malfunction  

Event Description

A turnpike spiral catheter was used in a patient procedure.The vessel had multiple granular modules, was very calcified and also had an under-deployed stent.The physician advanced the turnpike spiral catheter mid to distal vessel and encountered resistance.Resistance was encountered again when removing the turnpike spiral, but the device was able to be removed.After removing the turnpike catheter, the physician noticed that the nylon coil on the distal tip of the catheter was severely damaged, but the coil did not completely separate.No part of the catheter was left behind in the patient and no patient impact was reported.

• Brand Name: TURNPIKE SPIRAL
• 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: jacob schultz ; 6464 sycamore court north; maple grove, MN 55369 ; 7636564230
• MDR Report Key: 5311095
• MDR Text Key: 34738661
• Report Number: 2134812-2015-00045
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2015

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: Physician
• Device Expiration Date: 07/20/2017
• Device Model Number: 5640
• Device Lot Number: 585674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1