MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS Merit S-MAK¿; Dilator, Vessel, For Percutaneous Catheterization

Catalog Number	S-MAK401N
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction

• Brand Name: Merit S-MAK¿
• Common Device Name: Dilator, Vessel, For Percutaneous Catheterization
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 1600 w merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 1600 w merit parkway; south jordan UT 84095
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095 ; +1(801)208-4225
• MDR Report Key: 50548239
• Report Number: 1721504-2026-00437
• Device Sequence Number: 21483014
• Product Code: DRE
• UDI-Device Identifier: 00884450860342
• UDI-Public: 00884450860342
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K031691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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
• Device Catalogue Number: S-MAK401N
• 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: 08/07/2026
• Initial Report FDA Received Date: 09/01/2026
• 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
• Patient Sex: Unknown