MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT MEDICAL®; CARDIOVASCULAR PROCEDURE KIT

Model Number	INITIAL RELEASE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reported that there is a crack.

• Brand Name: MERIT MEDICAL®
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 24839063
• Report Number: 24839063
• Device Sequence Number: 6012027
• Product Code: OEZ
• UDI-Device Identifier: 00884450090763
• UDI-Public: (01)00884450090763
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/08/2026
• Report Date (Section F): 04/08/2026

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 Model Number: INITIAL RELEASE
• Device Catalogue Number: K09-14363
• Device Lot Number: H3395088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/08/2026