MalfunctionOWQ
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
Received May 25, 2021 · Event occurred May 12, 2021
Report 11874881 · MDR key 11874881
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
2148301
Product problems
- Defective Device
Patient
27375 DA
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MAGNETIC SENSOR ERROR, DID ENTER THE BODY BUT DID NOT CAUSE HARM, CATHETER EXCHANGED FOR NEW ONE. MAGNETIC SENSOR ERROR ON NEW CATHETER, DID ENTER THE BODY BUT DID NOT CAUSE HARM.