MalfunctionOWQ
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
Received Oct 21, 2021 · Event occurred Oct 6, 2021
Report 12672205 · MDR key 12672205
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
2157922
Product problems
- Communication or Transmission Problem
- Device Sensing Problem
Patient
28105 DA
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPROCESSED ICE CATHETER UNABLE TO DETECT TRANSDUCER WHEN CONNECTED TO ICE MACHINE, DID NOT ENTER BODY, TROUBLESHOOTING BY CARTO REPRESENTATIVE WITHOUT RESOLUTION, NEW DEVICE OPENED AND UTILIZED WITHOUT DIFFICULTY.