MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS IMPRESS®; DIAGNOSTIC INTRAVASCULAR CATHETER

Catalog Number	510038BER/JPB
Medical Device Problem Codes	Incomplete or Missing Packaging (2312); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that there was a defect in the packaging resulting in incomplete sterilization of the contents.The defect was identified during preparations for a medical procedure.No patient interaction or injury to report.

• Brand Name: IMPRESS®
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• 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 ; 8012084225
• MDR Report Key: 22445425
• Report Number: 1721504-2025-00142
• Device Sequence Number: 8118433
• Product Code: DQO
• UDI-Device Identifier: 00884450011485
• UDI-Public: 00884450011485
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K233268
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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
• Device Catalogue Number: 510038BER/JPB
• Device Lot Number: I3148490
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 03/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown