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

Catalog Number	56538BER/B
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2025
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
During a percutaneous embolization procedure of the uterine artery, the 'floppy' part of a catheter detached.These fragments, movied from the left external iliac artery to the popliteal bifurcation of the anterior tibial artery.During retrieval attempts, the catheter stump fragmented into multiple smaller pieces which required additional procedures and transfer to another facility to stabilize the patient.
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.BRAIDED.
• 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
• MDR Report Key: 23923569
• Report Number: 1721504-2025-00786
• Device Sequence Number: 21085973
• Product Code: DQO
• UDI-Device Identifier: 00884450654545
• UDI-Public: 00884450654545
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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 Catalogue Number: 56538BER/B
• Device Lot Number: I2997556
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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; Other; Life Threatening
• Patient Sex: Female