MalfunctionOWQ
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
Received Oct 7, 2024 · Event occurred Sep 6, 2024
Report 20383048 · MDR key 20383048
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
221431105212025
Patient
82 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ULTRASOUND CATHETER IMAGE BECAME UNCLEAR - INTERFERENCE. ERROR MESSAGE PRESENT ON CARTO CONSOLE. WHILE IN BODY. NO PATIENT HARM.