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 Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/20/2018
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 to complete an evaluation on.Therefore, the most likely root cause for the failure is undeterminable.
Event or Problem Description
During a ptca procedure, after an unsuccessful attempt of use of the turnpike spiral catheter, it was retrieved out from patient.However, dr.Found that the tip of the turnpike spiral catheter was damaged and a little part of the radiopaque tip was missing from the catheter and left in patient body.The procedure was then completed with other catheters.The patient was monitored after the procedure and then was discharged without any adverse event.Reported as no impact to patient.
Additional Manufacturer Narrative
There was no returned product for this event, however, images of the turnpike were provided.The images show severe damage to the distal tip of the catheter.The tip is also twisted and deformed.Based on the images (below) the damage is consistent with torquing the catheter against resistance.
Event or Problem Description
Additional information received which also included images: the patient was discharged without adverse event and no additional medical intervention.The missing piece from the patient was not retrieved.The device was used per the ifu.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN
• MDR Report Key: 7367234
• Report Number: 2134812-2018-00016
• Device Sequence Number: 1718194
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/25/2019
• Device Model Number: 5640
• Device Lot Number: 615137
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 04/18/2018
• Patient Sequence Number: 1