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

Catalog Number	MAK405/D
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a femoral angiogram procedure the device separated from the hub.When the provider twisted the syringe onto the hub of the micropuncture sheath, it detached from the sheath and left the shaft inside the vessel.The patient had to be taken to vascular surgery for sheath removal.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The body of the dilator had disconnected from the hub.The likely root cause of the failure can be attributed to human error.Likely, the device experienced excessive torsional force during use which caused the body of the dilator to separate from the hub.A search of the complaint database was performed and fourteen similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: MERIT MAK¿
• Common Device Name: VASCULAR DILATOR, SINGLE-USE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana inés de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana inés 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: 23720198
• Report Number: 1721504-2025-00650
• Device Sequence Number: 15977661
• Product Code: DRE
• UDI-Device Identifier: 00884450011454
• UDI-Public: 00884450011454
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K031691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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
• Device Catalogue Number: MAK405/D
• Device Lot Number: I3289346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown