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

Catalog Number	410038MPA1
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
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
Account reported during a biliary drain placement for biliary obstruction due to post hepaticojejunostomy stenosis, an attempt was made to advance a catheter over the wire into the small bowel in order to perform a wire exchange.There was resistance at the site of obstruction and it was noted that the tip of the catheter was broken and upon removing the catheter from the patient, the tip of the catheter remained in the patient.No snares were available, therefore the catheter fragment was left in the patient.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.A photo of catheter tip within the anatomy without the catheter shaft was provided.However, the root cause of the occurrence is inconclusive.The ifu review the catheter indication for use states the catheter is designed to be used intravascularly; however, in this case they inserted the catheter into the biliary system.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.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.Physical and visual evaluation were conducted and acceptable external material melt flow was observed, indicating sound tip to shaft joints were achieved during manufacturing.Per the ifu review, the catheter indication for use states the catheter is designed to be used intravascularly.Since this case involves insertion into the biliary system, only potential contributing factor is user error.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®
• 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: 23967593
• Report Number: 1721504-2025-00788
• Device Sequence Number: 11994016
• Product Code: DQO
• Combination Product (Y/N): N
• Initial Reporter Country: JM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2025
• Device Catalogue Number: 410038MPA1
• Device Lot Number: E2486063
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 02/12/2026; 05/21/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/13/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Unknown