MAUDE Adverse Event Report: STERILMED, INC. SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	R10439011
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Soundstar ice (intracardiac echocardiography) catheter had a sensor catheter error.Removed from body and new catheter inserted.Resolved issue.No harm to patient.

• Brand Name: SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n ste 2; plymouth MN 55446
• MDR Report Key: 19115025
• Report Number: 19115025
• Device Sequence Number: 12538368
• Product Code: OWQ
• UDI-Device Identifier: 10888551045087
• UDI-Public: (01)10888551045087
• 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): 03/26/2024
• Report Date (Section F): 03/26/2024

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: R10439011
• Device Catalogue Number: R10439011
• Device Lot Number: 2204523
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2024
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White
• Date Report Sent to FDA: 03/26/2024