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	01/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned product evaluation confirmed the distal tip had about 6-8mm missing.The catheter shaft showed signs of damage consistent with over torquing.A manufacturing record review was completed and zero nonconformances were found.The most likely root cause for this failure is damage during use.
Event or Problem Description
Spiral portion of catheter broke off in coronary artery.Retrograde access obtained and reverse cart done and stents deployed to embed spiral in arterial wall.As unable to retrieve it after multiple attempts.As reported: "the patient is fine.The piece of nylon was left behind in the artery and stented over to prevent it from moving." unfortunately unable to give specific information about the patient due to the (b)(4) privacy laws.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7300837
• Report Number: 2134812-2018-00010
• Device Sequence Number: 957391
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2018

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: Physician
• Device Expiration Date: 08/24/2019
• Device Model Number: 5640
• Device Lot Number: 612252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/27/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention