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

Model Number	5566
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.Communication with the physician confirmed that the physician was inserting the trapliner into the co-pilot, his hands went at an angle accidentally and he bent the pushrod at the weld.He then tried to straighten the pushrod back out and it broke, at the weld, in his hands outside of the patient.The two pieces were in his hands, so no harm to the patient.The most likely root cause for the separation was operational context and unintended user error.
Event or Problem Description
It was reported that the physician was pushing the guide extension of the trapliner through the co-pilot and it snapped before entering the patient.No further complications were reported.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 9883531
• Report Number: 2134812-2020-00029
• Device Sequence Number: 2320488
• Product Code: DQY
• UDI-Device Identifier: 10841156100544
• UDI-Public: (01)10841156100544(17)210104(10)639824
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 01/04/2021
• Device Model Number: 5566
• Device Catalogue Number: 5566
• Device Lot Number: 639824
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1