MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO DURAMAX HEMODIALYSIS CATHETER

Catalog Number	H787103028045/A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record was performed and no exception documents were identified.A review of the complaint database was performed and one similar complaint for this lot number was found.
Event or Problem Description
The account alleges the introducer failed to split cleanly.With an extra peel way, extra wire, and a micro puncture set they were able to keep access and prevent an air embolus.
Additional Manufacturer Narrative
H6 updated b, c and d codes.H11 added investigation summary.No units were physically returned for this complaint; however, the customer provided photographs of this defect which confirmed that the sheath failed splitting.Based on the investigation, it has been determined that the root cause was human error during the segregation of processed parts versus non-processed parts, which prevented the inspection of the unit.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and one similar complaint for this lot number were identified.

• Brand Name: DURAMAX HEMODIALYSIS CATHETER
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21644413
• Report Number: 3011642792-2025-00025
• Device Sequence Number: 7694727
• Product Code: MSD
• UDI-Device Identifier: 00884450786161
• UDI-Public: 00884450786161
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: H787103028045/A
• Device Lot Number: I3004072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2024
• 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
• Patient Sex: Unknown