FDA Adverse Event
Malfunction
Summary report: N
EVERCROSS
MDR report key: 1613890
·
Received February 11, 2010
Report
- Report Number
- 1613890
- Event Type
- Malfunction
- Date Received
- February 11, 2010
- Date of Event
- January 21, 2010
- Report Date
- January 26, 2010
- Manufacturer
- EV3 INC.
- Product Code
- LIT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
EQUIPMENT MALFUNCTION WHICH CAUSED BLEEDING DURING INTERVENTIONAL RADIOLOGY PROCEDURE. PT UNDERWENT RIGHT LOWER EXTREMITY ANGIOGRAM FOLLOW-UP STUDY. ANGIOPLASTY AND STENT PLACEMENT BY PHYSICIAN. EV3 DILATATION CATHETER MALFUNCTIONED: DIFFICULTY TRACKING THE BALLOON OVER THE GUIDE WIRE PRE-INFLATION, AND POST-INFLATION, WITH BALLOON DOWN, THE BALLOON WAS STUCK IN SHEATH, NECESSITATING REMOVAL OF CATHETER SYSTEM AND RE-INSERTING A NEW DILATATION BALLOON CATHETER, WHICH CAUSED SOME MINOR BLEEDING AT THE SITE. THE DEVICE WAS RETURNED TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVERCROSS | CATHETER, ANGIOPLASTY, PERIPHERAL | LIT | EV3 INC. | AB35W08040080 | 8083587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |