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

Catalog Number	56535RIM/B
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a venous stent procedure, the catheter tip detached and migrated to the heart.This occurred during the cross over to assess the opposite side of the patient prior to placing the stent.The patient was admitted to the hospital.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and the complaint is confirmed.The connection between the black tip and purple catheter appeared damaged and frayed and the fusion between the two parts was incomplete.The tip detachment likely resulted from a combination of human error and machine settings, and the frayed section seems to be due to manufacturing.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot were identified.

• 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; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22909979
• Report Number: 1721504-2025-00323
• Device Sequence Number: 9130797
• Product Code: DQO
• UDI-Device Identifier: 00884450654538
• UDI-Public: 00884450654538
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/26/2026
• Device Catalogue Number: 56535RIM/B
• Device Lot Number: I2634092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown