MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO S-MAK COAXIAL STIFFENED MINI ACCESS KIT

Catalog Number	S-MAK501N/A
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges the tip of the wire (less than 1mm) detached in the soft tissue of the neck during the procedure.The interventional radiologist and pediatric surgeon recommended no intervention, intentionally leaving the tip of the wire within the tissue.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the complaint database was performed and no similar complaints for this lot were identified.A review of the device history record was performed and no exception documents were found.

• Brand Name: S-MAK COAXIAL STIFFENED MINI ACCESS KIT
• Common Device Name: MINI ACCESS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21420480
• Report Number: 3011642792-2025-00008
• Device Sequence Number: 7763731
• Product Code: DRE
• UDI-Device Identifier: 00884450012642
• UDI-Public: 00884450012642
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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: S-MAK501N/A
• Device Lot Number: I3065842
• 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: 02/03/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2024
• 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
• Patient Sex: Unknown