MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. K12 ANGIOGRAPHY KIT; ANGIOGRAPHY/ANGIOPLASTY KIT

Catalog Number	K12-02551A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that the wire had sheared into multiple threads while inside the patient.The device was removed successfully.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and the complaint was confirmed.Root cause is unable to be determined.A review of the device history record was performed and no exception documents were identified.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: K12 ANGIOGRAPHY KIT
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY 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
• MDR Report Key: 22072774
• Report Number: 1721504-2025-00074
• Device Sequence Number: 18320658
• Product Code: OEQ
• UDI-Device Identifier: 00884450204498
• UDI-Public: 00884450204498
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/24/2025

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: K12-02551A
• Device Lot Number: H3157751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown