MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. TRAPLINER CATHETER

Model Number	5568
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trapliner was returned for investigation.The distal section was separated in two pieces after it had been removed from the patient the product was contaminated with biological matter and was not able to be inflated to observe for leaks.The distal area of the balloon push rod was bent.The traveler was reviewed no nonconformances were associated with this event.Root cause is determined to be misuse by clinician.
Event or Problem Description
The physician noticed a kink in the distal backbone of the trapliner.When a tech picked up the trapliner after it had been removed from the patient, the device separated into 2 pieces.

• Brand Name: TRAPLINER CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6397706
• Report Number: 2134812-2017-00030
• Device Sequence Number: 925611
• Product Code: DQY
• UDI-Device Identifier: M20655680
• UDI-Public: +M20655680/$$3181115600385/
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161901
• 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): 02/10/2017

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: 11/15/2018
• Device Model Number: 5568
• Device Lot Number: 600385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 03/11/2017
• Patient Sequence Number: 1