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

Model Number 5640

Device Problems Detachment Of Device Component (1104); Material Separation (1562); Device Contamination with Chemical or Other Material (2944)

Patient Problem Vascular Dissection (3160)

Event Date 10/12/2016

Event Type  Injury  

Event Description

After removal of the turnpike spiral from the patient, the tip was separated off the catheter and stuck on the wire.The turnpike spiral did its job in crossing a tight tortuous diagonal from a vein graft.It had to make a 180 degree turn at the anastomosis and then advance retrograde up the diagonal to cross the lesion.Wire and turnpike spiral position was lost, probably due to lack of support with the guide they used.Then physician pulled everything out and started over without having to intervene to get the turnpike out.When they looked at the wire, they noticed a small black piece about an inch in front of the turnpike spiral itself.It did not stay in the patient.No other device was used after the turnpike spiral because after loss of position, physician was able to re-wire the lesion but created a dissection so the case was abandoned.The patient did fine with no events and went home that afternoon.

Manufacturer Narrative

The event description along with the returned product evaluation provided sufficient evidence to determine that the most likely root cause was damage during use.The event description states that the turnpike was being used in a tight tortuous vessel.The damage seen on the returned device is consistent with torquing and rotating in a tortuous environment.

• Brand Name: TURNPIKE SPRIAL
• 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: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 6137748
• MDR Text Key: 61201412
• Report Number: 2134812-2016-00087
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K14065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/06/2017
• Device Model Number: 5640
• Device Lot Number: 586686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention