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

Model Number	5640
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/12/2016
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6137748
• Report Number: 2134812-2016-00087
• Device Sequence Number: 1075324
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K14065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 12/28/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention