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

Catalog Number	H965103028051
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Separation Problem (4043); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
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 valved breakaway introducer failed to split upon attempting to remove.No patient injury.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation; however, the customer submitted photographic evidence clearly demonstrating that the sheath introducer had a an irregular, wavy deformation at the onset of splitting.The complaint could not be confirmed.The root cause could not be established.This device was manufactured prior to the acquisition.

• Brand Name: DURAMAX®
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• 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: 23085437
• Report Number: 1721504-2025-00353
• Device Sequence Number: 10559640
• Product Code: MSD
• UDI-Device Identifier: 00884450793220
• UDI-Public: 00884450793220
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: H965103028051
• Device Lot Number: 5810288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown