MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. DURAMAX®; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	H787103028185/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
In a randomized clinical study evaluating the performance of the duramax® tunneled hemodialysis catheter identified a case of catheter-related infection.These infections necessitated early catheter removal.The incidence rate of cri in the dm group was 1.14 events per 1,000 catheter days, which was notably higher than the comparator group's rate of 0.67 events per 1,000 catheter days.All catheters were implanted without procedural complications.This report is being submitted as a serious injury due to the need for medical intervention and early device removal.

• Brand Name: DURAMAX®
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22384396
• Report Number: 1721504-2025-00130
• Device Sequence Number: 9055654
• Product Code: MSD
• UDI-Device Identifier: 00884450786178
• UDI-Public: 00884450786178
• Combination Product (Y/N): Y
• Initial Reporter Country: EI
• PMA/510(K) Number: K101843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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
• Device Catalogue Number: H787103028185/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown