MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO AGIOGRAPHY CUSTOM K12 KIT; ANGIOGRAPHY/ANGIOPLASTY KIT

Catalog Number	K12T-05608A
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges the one step catheter was placed in the patient and a 50 ml luer lock syringe was attached to obtain fluid for labs.The fluid was drawn into the syringe.The hub then broke off into the luer lock when twisting the syringe to remove it from the one step catheter.This prevented the iv line from being attached to the catheter.The clinician removed the catheter and inserted another to complete the procedure.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.According to internal procedures this assembly operation is manual and therefore susceptible to human error.During assembly, the valve with a slit must be properly placed into the valve body.The valve body and luer/valved connector are then assembled and welded together.It is possible that during this process, the valve was not correctly seated or positioned, leading to detachment during use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: AGIOGRAPHY CUSTOM K12 KIT
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY 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
• MDR Report Key: 22437646
• Report Number: 1721504-2025-00143
• Device Sequence Number: 4745711
• Product Code: OEQ
• UDI-Device Identifier: 00884450345443
• UDI-Public: 00884450345443
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 08/06/2025

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 Expiration Date: 12/28/2025
• Device Catalogue Number: K12T-05608A
• Device Lot Number: T3211558
• 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: 06/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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