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

Catalog Number	510038BER/JP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Account report that during treatment of an endoleak in a stent-graft, the black tip of the impress catheter detached.The operator handled the impress carefully in this case and did not perform any excessive manipulation.He also reported that the impress did not get caught on the stent graft or otherwise exert excessive pressure.The tip was retrieved with a cut-down and a 14fr cook check-flo.It was found that the complaint product had passed its expiration date.
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.A photo of fluoroscopy imaging coincides with the reported issue.It was noted that the expiration date of this lot is 02-jan-2026 and the case indicated the incident occurrence date of (b)(6) 2026.The exact root cause of the failure is unknown.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number 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: 24312515
• Report Number: 1721504-2026-00868
• Device Sequence Number: 4875152
• Product Code: DQO
• UDI-Device Identifier: 00884450011485
• UDI-Public: 00884450011485
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/03/2026

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: 01/02/2026
• Device Catalogue Number: 510038BER/JP
• Device Lot Number: E2594227
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown