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

Catalog Number	510038MPA1-H/B
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that during use the tip of the catheter broke off inside the patient while trying to pass through the thrombus multiple times.This occurred while attempting to pass a clot in the left illiac vein.The tip of the catheter became lodged within the clot.The tip of the catheter was not retrieved and remains within the patient.
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 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.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: IMPRESS®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23648684
• Report Number: 1721504-2025-00651
• Device Sequence Number: 10123367
• Product Code: DQO
• UDI-Device Identifier: 00884450697313
• UDI-Public: 00884450697313
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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 Catalogue Number: 510038MPA1-H/B
• Device Lot Number: I2927425
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• 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