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

Catalog Number	H787103028045/A
Medical Device Problem Codes	Material Separation (1562); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device will not be returning for engineering evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
Event or Problem Description
The account alleges that when placing a tunneled hemodialysis catheter, the tear away portion of the hemodialysis catheter malfunctioned, causing one side to peel away and the other to remain in place.Ultimately the physician was able to remove the portion that did not peel away, causing no harm to the patient.
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and two similar complaints were identified.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
Additional report received on medwatch mw5166355.
Additional Manufacturer Narrative
B5 updated.G2 added other.H6 updated codes.H10 related report number added.H11 evaluation per photos.No units were physically returned for this complaint; however, the customer provided photographs of this defect which confirmed that the sheath failed splitting.According to the photos provided by the customer, it can be seen that the pod was not split correctly.The reported failure mode was confirmed with the shared pictures of the device and the investigation carried out through the production line.The root cause was human error during the segregation of processed parts versus non-processed parts, which prevented the inspection of the unit.B5 updated.

• Brand Name: DURAMAX.CATHETER.CHRONIC HEMODIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21554481
• Report Number: 3011642792-2025-00017
• Device Sequence Number: 8165242
• Product Code: MSD
• UDI-Device Identifier: 00884450786161
• UDI-Public: 884450786161
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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 Catalogue Number: H787103028045/A
• Device Lot Number: I3072554
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 03/27/2025; Not provided
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/27/2025; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• 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 Age: 62 YR
• Patient Sex: Male