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

Catalog Number	5903510PIG-NB
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/27/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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.Non-conformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Event or Problem Description
The account alleges that a 71-year-old male with significant comorbidities underwent emergency aortography on (b)(6) 2025, for suspected mesenteric arterial ischemia.The patient was critically ill prior to the procedure, with hemodynamic instability, intubation, and vasoactive support.During removal of the guidewire and exit of the pigtail catheter from the introducer, fragmentation of the catheter tip was identified under fluoroscopy.No irregularities were observed prior to use.The black pigtail segment fragmented during retrieval, resulting in five fragments; one was recovered, and four embolized to the left hypogastric artery and left proximal superficial femoral artery.Snare-based retrieval was attempted with partial success; complete extraction was not possible.Due to the patient's deteriorating condition, no further intervention was performed at that time.Another catheter from the same lot fragmented upon removal from the packaging during the same procedure.The patient died on (b)(6) 2025.Cause of death was documented as multi-organ failure.The attending physician stated that the catheter fragmentation was not the ultimate cause of death but contributed by delaying other required vascular procedures.

• 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: 24021718
• Report Number: 1721504-2026-00813
• Device Sequence Number: 13410408
• Product Code: DQO
• UDI-Device Identifier: 00884450688236
• UDI-Public: 00884450688236
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2026
• Device Catalogue Number: 5903510PIG-NB
• Device Lot Number: E2635632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male