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

Model Number	5566
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	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One-unit of trapliner model 5566 was returned to vsi for evaluation.A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.On inspecting the product, separation was confirmed at the weld joint between half pipe and hypo-tube.No other damage was seen at the length of the catheter.As per ifu (instruction for use) it states to "exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage or kinking.Do not apply torque to the catheter during delivery, as catheter damage may result." based on the return product evaluation and the information provided, the most likely root cause for this failure is operational context and unintended user error.
Event or Problem Description
The trapliner had been backloaded over the guidewire and was going to be advanced into the valve when it broke.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9653871
• Report Number: 2134812-2020-00013
• Device Sequence Number: 16580168
• Product Code: DQY
• UDI-Device Identifier: 20841156102125
• UDI-Public: (01)20841156102125
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

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: 10/14/2021
• Device Model Number: 5566
• Device Lot Number: 659961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1