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

Catalog Number	H787103028185/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reports the sheath broke at the wrong location; physician had to retrieve it from within the patient.No additional details were provided.
Additional Manufacturer Narrative
This event was identified during internal quality system activities.Upon review, the manufacturer determined the event meets fda criteria for reporting.The report is being submitted to ensure accuracy and completeness of mdr files.This submission does not reflect a change in device performance or patient risk.The awareness date corresponds to when the manufacturer became aware of the event details.All information reasonably known to the manufacturer at this time has been included.The suspect device was not returned for evaluation.This complaint will be used to trend for similar complaints.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.The complaint could not be confirmed and the root cause could not be determined.

• Brand Name: DURAMAX®
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; 19970-b roberto de la madrid; tijuana bc, 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; 19970-b roberto de la madrid; tijuana bc, 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; calle, sor juana ines de la cr; 19970-b roberto de la madrid; tijuana 22630
• MDR Report Key: 24735053
• Report Number: 1721504-2026-00105
• Device Sequence Number: 13367459
• Product Code: MSD
• UDI-Device Identifier: 00884450786178
• UDI-Public: 00884450786178
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 08/30/2026
• Device Catalogue Number: H787103028185/A
• Device Lot Number: I2929319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown