MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC IMPRESS®; ANGIOGRAPHIC CATHETER, SINGLE-USE

Catalog Number	58038MIK/CN
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that during bronchial artery infusion chemotherapy and embolization, the distal end of the angiographic catheter fractured into multiple segments inside the patient's body.Immediate retrieval was attempted using a snare device, which required several hours.Several fragments were successfully removed; however, one residual catheter segment remains in the patient's iliac artery.The patient is currently under close observation.
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 not returned for evaluation.The investigation was conducted using a photo provided by the complainant.This complaint could not be confirmed.The root cause could not be established.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: IMPRESS®
• Common Device Name: ANGIOGRAPHIC CATHETER, SINGLE-USE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23995566
• Report Number: 1721504-2026-00794
• Device Sequence Number: 13394515
• Product Code: DQO
• UDI-Device Identifier: 00884450789049
• UDI-Public: 00884450789049
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 02/06/2026

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: 02/16/2026
• Device Catalogue Number: 58038MIK/CN
• Device Lot Number: E2622655
• 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: 12/25/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown