MalfunctionOWQ
N/A
Received Nov 20, 2024 · Event occurred Oct 22, 2024
Report 20733691 · MDR key 20733691
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
2218751
Patient
61 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SOUNDSTAR INSERTED INTO BODY, CATHETER SENSOR ERROR. PRODUCT REMOVED. NO HARM TO PATIENT. DIFFERENT CATHETER OPENED. PROBLEM SOLVED.