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

Catalog Number	H787103028185/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
In a randomized clinical study evaluating the performance of the duramax® tunneled hemodialysis catheter identified a case of catheter dislodgement.All devices were placed without technical difficulty or procedural complications.However, the dm catheter group exhibited a disproportionately higher rate of dislodgement compared to the comparator device group, which had only one dislodgement, and that patient had a prior dislodgement history with a dm catheter.These dislodgement events required early catheter removal.This report is being submitted as a potential device malfunction that may lead to serious injury if the issue were to recur.
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.

• 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: 22384384
• Report Number: 1721504-2025-00125
• Device Sequence Number: 8700249
• Product Code: MSD
• UDI-Device Identifier: 00884450786178
• UDI-Public: 00884450786178
• Combination Product (Y/N): N
• 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