MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TRAPLINER; CATHETER

Model Number	5567
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.A manufacturing record review was completed and no related nonconformances were found supporting the device met material, assembly and performance specifications.
Event or Problem Description
Trapliner broke at transition point while it was being advanced into the guide catheter, physician removed the trapliner.Completed with a different device.No patient injury or impact reported.The device was reported as discarded at the facility.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9328132
• Report Number: 2134812-2019-00075
• Device Sequence Number: 2272204
• Product Code: DQY
• UDI-Device Identifier: 10841156102135
• UDI-Public: (01)10841156102135
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2019

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: Health Professional
• Device Expiration Date: 07/12/2021
• Device Model Number: 5567
• Device Catalogue Number: 5567
• Device Lot Number: 652982
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention