MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MICROCATHETER.MERIT MAESTRO®; CATHETER, CONTINUOUS FLUSH

Catalog Number	28MC24130SN
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.
Event or Problem Description
Customer alleged the tip of catheter was detached during a tace (transarterial chemoembolization) procedure.The procedure was completed with a new device.No reported injury.

• Brand Name: MICROCATHETER.MERIT MAESTRO®
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 25243531
• Report Number: 1721504-2026-00058
• Device Sequence Number: 10548474
• Product Code: KRA
• UDI-Device Identifier: 00884450013915
• UDI-Public: 00884450013915
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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
• Device Catalogue Number: 28MC24130SN
• Device Lot Number: H3421583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown