MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MAK-NV¿; VASCULAR DILATOR, SINGLE-USE

Catalog Number	MAK-NV-002/CNA
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that while advancing the dilator sheath over the guidewire, resistance was encountered, and the sheath could neither be advanced nor withdrawn.Both the guidewire and sheath were then removed together, revealing that the guidewire surface was frayed, likely due to relative cutting interaction with the puncture needle, resulting in a significant segment of deformation.No patient injury.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The photograph provided showed the coil had unravelled, but were insufficient to determine a root cause.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaint for this lot number was found.

• Brand Name: MAK-NV¿
• Common Device Name: VASCULAR DILATOR, SINGLE-USE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23995541
• Report Number: 1721504-2026-00790
• Device Sequence Number: 10239769
• Product Code: GCB
• UDI-Device Identifier: 00884450820612
• UDI-Public: 00884450820612
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: MAK-NV-002/CNA
• Device Lot Number: I2903295
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown