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

Catalog Number	59038UAC/B
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
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
The account alleges that the catheter was broken prior to opening the package.No patient harm or injury.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.Visual inspection found the black tip of the catheter detached from the catheter body.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 engineering, quality, and management team members.

• Brand Name: IMPRESS BRAIDED CATHETER
• Common Device Name: BRAIDED CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana in?s de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22522717
• Report Number: 1721504-2025-00156
• Device Sequence Number: 12765319
• Product Code: DQO
• UDI-Device Identifier: 00884450661529
• UDI-Public: 00884450661529
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 59038UAC/B
• Device Lot Number: I2918530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown