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

Model Number	5621
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event description states that the turnpike gold catheter broke apart in a very calcified lower extremity while torquing and pushing the catheter.A manufacturing record review was completed and zero nonconformances were found.The returned product evaluation confirmed the damage to the catheter.The catheter shaft was severely twisted due to torque.About 10 cm of the distal shaft was separated and not returned with the device.The most likely root cause for this failure is damage during use.
Event or Problem Description
An (b)(6) male with diabetes with very calcified segment in the lower extremities below the at in the top of foot.After trying a turnpike spiral which did not advance, the doctor used a turnpike gold advanced through the very difficult calcium by torquing clockwise and pushing the catheter as it moved down the vessel.Once through he was trying to remove the turnpike gold with counter clockwise turns and the catheter was not moving, so he kept torquing the turnpike gold.The catheter and wire broke apart.Fifteen (15) cm of turnpike gold and wire was left in vessel after trying to snare with no success.Doctor said it was not an issue with the turnpike gold.Sent patient to the operating room (or) for retrieval.

• Brand Name: TURNPIKE GOLD
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6816834
• Report Number: 2134812-2017-00067
• Device Sequence Number: 150478
• Product Code: DQY
• UDI-Device Identifier: M20656210
• UDI-Public: M20656210
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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: Physician
• Device Expiration Date: 02/23/2019
• Device Model Number: 5621
• Device Lot Number: 604700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR