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

Catalog Number	46535RIM/B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A radiologist was performing an iliac angioplasty.While attempting to pass catheter through stenosed iliac artery, around 5cm of tip of catheter broke off and had to be retrieved.The radiologist was able to retrieve the tip by using an angioplasty balloon and stent to open vessels around fragment.No reported injury or additional patient details were provided.
Additional Manufacturer Narrative
A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The tip was detached from the body of the device.This complaint is confirmed.The most likely root cause of the failure can be attributed to an incomplete fusion between the teflon sleeve and the body of the device can ultimately lead to the tip of the device detaching during use.A search of the complaint database was performed and one similar complaint for this lot number was 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®
• 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 w merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 22731505
• Report Number: 1721504-2025-00223
• Device Sequence Number: 18228853
• Product Code: DQO
• UDI-Device Identifier: 00884450668122
• UDI-Public: 00884450668122
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 46535RIM/B
• Device Lot Number: I2880857
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown