MalfunctionOWQ
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
Received Jun 6, 2022 · Event occurred Apr 15, 2022
Report 14601335 · MDR key 14601335
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Product problems
- Poor Quality Image
- Material Twisted/Bent
Patient
27375 DA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CATHETER HAS A BEND. SUBOPTIMAL IMAGE QUALITY. NO PATIENT HARM.