MalfunctionOWQ
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
Received Sep 15, 2021 · Event occurred Sep 2, 2021
Report 12473765 · MDR key 12473765
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
2156758
Product problems
- Defective Device
Patient
25185 DA
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ERROR MESSAGE: ¿NOT RECOGNIZED BY CARTO SYSTEM¿. DEVICE DID NOT ENTER THE BODY OR HARM PATIENT. NEW DEVICE OPENED W/O FURTHER ISSUES.