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

Model Number	5640
Medical Device Problem Codes	Use of Device Problem (1670); Separation Problem (4043)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device evaluation confirmed the reported failure.The catheter showed signs of damage consistent with torquing in heavy calcification and the distal nylon coil was separated and not returned.It is unknown if the separated section of coil was left in the patient or removed.The ends of the nylon coil were both connected and fully reflowed to the shaft supporting the fact that the device met material, assembly, and performance specifications.A manufacturing record review was completed and zero nonconformances were found.The most likely root cause for this failure is damage during use.
Event or Problem Description
In a very tortuous rca lesion, the doctor used turnpike spiral.After being advanced around 3 mm, it could no longer be advanced; the doctor re-treated the turnpike a bit and tried to advance again, but still could not advance it.Finally the doctor withdrew the turnpike and found the outer coil has been come off from the catheter.Additional information received 02jul18.Patient data is confidential.The catheter was removed and the user found the coil came off but still visible on the catheter.The user said there was no additional torquing.The tip caught in the occlusion of the lesion section.No further retrieve device was used for the coil.The patient was sent to surgery at a later time, the physician found a guidewire was broken (not related to the use of turnpike) in the vessel and it was unable to keep doing the intervention.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7678562
• Report Number: 2134812-2018-00046
• Device Sequence Number: 658583
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: Health Professional
• Device Expiration Date: 12/30/2018
• Device Model Number: 5640
• Device Lot Number: 602618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention