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

Model Number	5640
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was also completed and confirmed the tip separated.The turnpike was returned with the guidewire stuck inside.The guidewire was severely damaged.The tip section was separated and remained on the wire.The separated piece of the tip was twisted and locked on the wire.Both ends of the distal nylon coil were fully reflowed and the coil was not damaged.The damage is consistent with over torqueing the catheter in a calcified lesion.
Event or Problem Description
During a cto case in the rca the tip of the turnpike spiral separated from the catheter.Resistance was felt during the procedure.Physician was able to remove the tip and catheter.Additional information received 06may19: the tip was stuck on the wire, so the catheter and wire were removed together.No medical intervention was reported.Outcome of patient is reported as fine.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8655411
• Report Number: 2134812-2019-00038
• Device Sequence Number: 2072630
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/30/2019

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: Health Professional
• Device Expiration Date: 11/08/2020
• Device Model Number: 5640
• Device Lot Number: 637211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1