MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MERIT S-MAK¿ COAXIAL MINI ACCESS KIT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	S-MAK401N/C
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges while gaining access for a coronary arteriogram procedure, the tip of the micro puncture wire sheared off while in the vessel. the needle was inserted into the vessel and advanced.Some minimal resistance was met, so the device was pulled back and attempts to redirect were made.The attempted redirection was unsuccessful, so the device was removed.The clinician identified the sheared tip when removing the micro puncture sheath and wire due to the need to re-stick the access site. the patient was noted to have unique anatomy which required insertion at an unusual angle.Several attempts were made to snare/retrieve retained wire but were unsuccessful.  vascular surgery was consulted and the decision was made to bring patient to the for a cutdown, exploration, and removal of retained wire.The foreign body was successfully retrieved.No addtional patient consequence to report.
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.No lot number was provided; thus, the device history record could not be reviewed and a search of the complaint database could not be performed.

• Brand Name: MERIT S-MAK¿ COAXIAL MINI ACCESS KIT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22717377
• Report Number: 1721504-2025-00221
• Device Sequence Number: 9132575
• Product Code: DRE
• UDI-Device Identifier: 00884450012635
• UDI-Public: 00884450012635
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/10/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: S-MAK401N/C
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown