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

Model Number	5640
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found.There was no returned product for evaluation.Based on the event details, the most likely root cause is damage during use.Site risk managment has not released the device for investigation.
Event or Problem Description
Physicians were working on an om2 following a wire.Got past the lesion with the wire, and the turnpike spiral.Upon trying to remove the turnpike spiral, they noticed the tip separated.It embolized and all efforts to retrieve the tip were not successful.They attempted to laser the lesion after this attempt failed.The patient was then transported to the or to have a 4 vessel cabg performed.Today the patient is doing ok.Information received from medwatch (identifier # not provided): during cardiac cath procedure, a turnpike spiral catheter was used in an attempt to cross a lesion in the om2 artery.Catheter would not pass and was noted to be torqued in the lesion causing the tip to shear off and embolized in the vessel.When attempting to exchange the wire with a turnpike lp wire, the embolized tip became lodged and occluded blood flow.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7476590
• Report Number: 2134812-2018-00033
• Device Sequence Number: 19202882
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/03/2018

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: Physician
• Device Expiration Date: 02/09/2020
• Device Model Number: 5640
• Device Lot Number: 620148
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 05/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 95