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

Model Number 5638

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

The wire and second turnpike device used in the procedure were returned to vsi for investigation, but the turnpike lp device in relation to this der was not.The guidewire was examined to see if the tip of the first turnpike device was still on the wire.The guidewire was found to have severe damage and the second turnpike device stuck on the wire.This turnpike was removed from the guidewire and a large blood clot was then removed from the device.No tip was found present on the wire or inside the second turnpike device.The turnpike device in relation to this complaint was not returned to vsi.It is therefore undeterminable if part of the tip did become detached or if the device just appeared to be "scrunched up".It can be confirmed that the tip was not stuck on the wire nor stuck inside the second turnpike device.

Event Description

Complex calcified lad, dr.Used turnpike with a run-through guidewire, he noticed the tip looked scrunched up, so removed the device and pulled another turnpike, and when he advanced it, the tip became stuck onto the wire.He had to remove the entire system.Additional info rec'd 12jun2018: the account believes part of the tip of the turnpike lp was detached and on the wire, and that is why the 2nd turnpike got stuck on the wire when they were advancing it.They ended up completing the procedure without a turnpike, they had to remove the entire system, and go back in again without the use of a micro catheter.It is reported, there was torquing of the catheter and the vessel was reported as tortuous and heavily calcified.No patient injury or impact.The current patient condition is reported as fine.

• Brand Name: TURNPIKE LP
• 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: 7664990
• MDR Text Key: 113396700
• Report Number: 2134812-2018-00044
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151981
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 5638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1