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	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformance's were found.The returned product evaluation confirmed that a piece of the distal tip was missing from the catheter.The separated piece was reported as left in the patient.The damage found on the catheter was consistent with over torqueing against resistance.
Event or Problem Description
Turnpike spiral was damaged.The information reported was the "wire came off the tip of the catheter in the vessel".It is reported that the tip was not retrieved and not on the wire.It was reported as no impact or injury to patient.The patient was stable leaving the lab.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7366991
• Report Number: 2134812-2018-00015
• Device Sequence Number: 16425169
• Product Code: DQY
• UDI-Device Identifier: M20656410
• UDI-Public: M20656410
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/22/2018

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: 04/07/2019
• Device Model Number: 5640
• Device Lot Number: 606531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/23/2018
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 93