MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. SURECROSS; CATHETER, PERCUTANEOUS

Model Number	SC35150/C
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned.A follow up report will be submitted once the device investigation is complete.The product history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were found.Nonconformances of this nature are monitored by the operations team.This complaint will be used to trend for similar complaints.
Event or Problem Description
It was reported that a marker band issue occurred prior to procedure.No patient injury or medical intervention was reported.No additional information is available.

• Brand Name: SURECROSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby dr; houston, TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 25233267
• Report Number: 3010665433-2026-00010
• Device Sequence Number: 16041525
• Product Code: DQY
• UDI-Device Identifier: 00884450644867
• UDI-Public: 00884450644867
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123311
• 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,Followup
• Report Date (Section B): 06/11/2026

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
• Device Model Number: SC35150/C
• Device Lot Number: E3220233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown