MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. SCOUT BX¿; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	00884450719596
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was here for a left breast biopsy with a savi scout placement.Biopsy was successful.Upon deploying the savi scout at 11:41 am, it was not definitively visualized with ultrasound.Mammo imaging confirmed that the savi scout reflector was not present.Patient came back to the ultrasound dept to attempt another savi scout placement.Second attempt was successful.Patient returned to the mammo dept for confirmation.

• Brand Name: SCOUT BX¿
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 24115046
• Report Number: 24115046
• Device Sequence Number: 15786477
• Product Code: NEU
• UDI-Device Identifier: 00884450719596
• UDI-Public: (01)00884450719596
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/12/2025
• Report Date (Section F): 12/12/2025

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
• Operator of Device: Health Professional
• Device Model Number: 00884450719596
• Device Catalogue Number: SSR13B-01/B
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/12/2025