MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS 10Fore¿; Angiography/Angioplasty Kit

Catalog Number	MAPTEN42
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury

• Brand Name: 10Fore¿
• Common Device Name: Angiography/Angioplasty Kit
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 1600 w merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095 ; +1(801)208-4225
• MDR Report Key: 50794590
• Report Number: 1721504-2026-00457
• Device Sequence Number: 16079712
• Product Code: OEQ
• UDI-Device Identifier: 00884450832509
• UDI-Public: 00884450832509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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?: No
• Device Catalogue Number: MAPTEN42
• Device Lot Number: H3290146S1
• 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: 08/18/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown