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

Model Number	5639
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event description states that the tip of the catheter broke off.A manufacturing record review was completed and zero nonconformances were found.The event details state the doctor was using the turnpike lp in a tortuous part of the lesion while trying to advance the catheter.The doctor pulled back on the catheter and noticed a piece of the tip was separated.The most likely root cause for this failure is damage during use.The tip was not removed from the patient, the tip was pushed to the distal end of the artery.It is reported the site will let us know if there was any follow up procedure to retrieve the tip of the device.It was indicated no patient harm.
Event or Problem Description
Physician was in a torturous part of the lesion and was trying to progress the catheter.In order to maneuver catheter it was pulled back and it was noticed the tip had broken off.Broken tip pushed to distal end of the artery.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6831566
• Report Number: 2134812-2017-00068
• Device Sequence Number: 65977
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: M20656390
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2017

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: No Information
• Device Expiration Date: 11/11/2018
• Device Model Number: 5639
• Device Lot Number: 600516
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention