MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. CUSTOM KIT

Catalog Number	K12-09098B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
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 and device history record cannot be performed as a lot number was not provided.
Event or Problem Description
The account alleges that a bridge guide wire from one of the prep kits broke apart inside the patient.The tip of the wire got stuck in the ivc and when the ep extractor pulled back the guide wire it slinkied apart.The physician was able to successfully snare the piece that broke off.

• Brand Name: CUSTOM KIT
• Common Device Name: CUSTOM KIT
• 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 ; 8012531600
• MDR Report Key: 21420479
• Report Number: 1721504-2025-00018
• Device Sequence Number: 20774332
• Product Code: OEQ
• UDI-Device Identifier: 00884450771310
• UDI-Public: 00884450771310
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: K12-09098B
• 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: 02/07/2025
• Initial Report FDA Received Date: 02/20/2025
• 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