MalfunctionOWQ
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
Received Aug 29, 2024 · Event occurred Jul 16, 2024
Report 20094804 · MDR key 20094804
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
2211855
Patient
72 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CATHETER INSERTED, BAD CONNECTIONS; DEVICE REMOVED; NEW CATHETER INSERTED; PROBLEM RESOLVED; NO HARM TO PATIENT.