FDA Adverse Event
Malfunction
Summary report: N
ULTRA ICE PLUS - PI
MDR report key: 11544494
·
Received March 22, 2021
Report
- Report Number
- 2134265-2021-03611
- Event Type
- Malfunction
- Date Received
- March 22, 2021
- Date of Event
- March 1, 2021
- Report Date
- March 22, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DXK
- UDI-DI
- 08714729982500
- PMA / PMN Number
- K181042
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435715 | ULTRA ICE PLUS - PI | CATHETER, ULTRASOUND, INTRAVASCULAR | DXK | BOSTON SCIENTIFIC CORPORATION | 1816-06 | 0026475575 | 08714729982500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |