MAUDE Adverse Event Report: STERILMED, INC. N/A; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	R10439236
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On insertion into body, no visible images.

• Brand Name: N/A
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n ste 2; plymouth MN 55446
• MDR Report Key: 24307587
• Report Number: 24307587
• Device Sequence Number: 12078723
• Product Code: OWQ
• UDI-Device Identifier: 10888551045094
• UDI-Public: (01)10888551045094
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/02/2026
• Report Date (Section F): 02/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: R10439236
• Device Catalogue Number: R10439236
• Device Lot Number: 2237418
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Date Report Sent to FDA: 02/02/2026