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	No Information (3190)
Date of Event	05/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being based on the visual investigation and condition of the returned sample.A manufacturing record review was completed and zero nonconformances were found.The returned product evaluation confirmed the damage to the distal tip section.There was a longitudinal tear in the distal tip but everything remained intact.Also, the mid-shaft of the catheter was kinked.The damage is consistent with over torquing against resistance.
Event or Problem Description
Doctor was unsuccessful in resolving this cto and will be attempting again in two months time.Could not progress through a retrograde approach and then proceeded with an antegrade approach.Could not penetrate the proximal cap.The turnpike gold was bent at a 45 degree angle with a wire stuck in it.The wire and turnpike had to be removed through the sheath together.Dr.Was attempting to navigate through the proximal cap of a mid.Circ.Lesion, 9 different wires were used, and 5 various turnpikes were also used.The tips of the lp and spiral catheters were deformed and had difficulty removing the wire.This report is associated to medwatch 2134812-2018-00022.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7441084
• Report Number: 2134812-2018-00023
• Device Sequence Number: 16401548
• 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,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

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: 09/21/2018
• Device Model Number: 5640
• Device Lot Number: 598950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 04/18/2018
• Patient Sequence Number: 1