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

Model Number	5639
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	10/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned, therefore an evaluation could not be completed.A manufacturing record review was completed and zero nonconformances were found, supporting the fact the device met material, assembly and performance specifications.Additional information received states the wire and the turnpike were both stuck in a lesion, and the doctor had to pull hard to remove.This is most likely the cause of the broken wire and tip separation on the turnpike.Without having the device returned, the root cause cannot be confirmed.Therefore, the root cause of this failure is undeterminable.
Event or Problem Description
A pilot 200 wire was used with the turnpike lp, when the wire was removed through the turnpike lp it was shredded.Additional information received (b)(6) 2018: after several attempts the turnpike lp did not pass the lesion, and then it got stuck in the lesion.The wire inside the turnpike lp was also stuck.Physician had to tug hard on them both and they both finally came out together.Physician noticed the tip of the wire was shredded, (the wire was shredded/unraveled.No parts separated completely) part of the turnpike lp tip adhered on to the wire.No fragments were left in the patient.After removing the wire and turnpike lp, physician said the lad and circumflex arteries 'shut down'.This resulted in patient chest pain and bump of troponin levels in the patient.Eventually physician was able to stabilize the patient who is doing fine.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8037608
• Report Number: 2134812-2018-00080
• Device Sequence Number: 19177352
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: +M20656390/$$3200824632319/
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• 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
• Report Date (Section B): 10/11/2018

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: 08/24/2020
• Device Model Number: 5639
• Device Catalogue Number: N/A
• Device Lot Number: 632319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/05/2018
• 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
• Patient Age: 78 YR