MalfunctionDXK
ULTRA ICE PLUS - PI
Received Mar 22, 2021 · Event occurred Mar 1, 2021
Report 2134265-2021-03611 · MDR key 11544494
Device
Generic name
Catheter, Ultrasound, Intravascular
Manufacturer
Boston Scientific CorporationModel number
1816-06Catalog number
1816-06
Lot number
0026475575
Product problems
- Poor Quality Image
- Poor Quality Image
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ULTRA ICE VASCULAR IMAGING CATHETER WAS SELECTED FOR USE IN THE ILIAC VEIN. THE CATHETER WAS PREPPED AND INSERTED THROUGH THE SHEATH. HOWEVER, NO IMAGE APPEARED ON THE SCREEN. THE CATHETER WAS REMOVED AND RE-FLUSHED BUT THERE STILL WAS NO IMAGE. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR A LATER DATE. THE PATIENT EXPERIENCED NO COMPLICATIONS.