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

Catalog Number	K09-11480
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The device history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.
Event or Problem Description
Customer reports a ppatient had right radial and right femoral artery accesses for chronic total occlusion intervention.During procedure, radial and femoral arterial transduced blood pressure significantly dropped simultaneously from 160s to 60s.There was a discrepancy between non-invasive blood pressure and transduced pressure.Due to low transduced pressure, pressors and inotropes were administered.Patient was intubated.Changed out acist transducer, so believe problem was in malfunctioning consumable/disposable manifold.

• Brand Name: CUSTOM KIT
• Common Device Name: CARDIOVASCULAR PROCEDURE 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: 25163776
• Report Number: 1721504-2026-00041
• Device Sequence Number: 8569802
• Product Code: OEZ
• UDI-Device Identifier: 00884450184233
• UDI-Public: 00884450184233
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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?: Yes
• Device Catalogue Number: K09-11480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown