MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT MAKNV 6FRENCH; NEEDLE, CATHETER

Model Number	MAK-NV-009
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A 6 fr maknv wire was used and the tip split into 2 different pieces inside the patient's kidney, both pieces were retrieved by surgeon and x-ray was taken to confirm no wire was left behind.

• Brand Name: MERIT MAKNV 6FRENCH
• Common Device Name: NEEDLE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 21786953
• Report Number: MW5168674
• Device Sequence Number: 18385985
• Product Code: GCB
• UDI-Device Identifier: 00884450088791
• UDI-Public: (01)00884450088791
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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 Model Number: MAK-NV-009
• Device Lot Number: 13065695
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2025
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female