FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD20
MDR report key: 1872910
·
Received October 4, 2010
Report
- Report Number
- 3003768277-2010-00234
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 8, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD, RESULTS AND CONCLUSIONS - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THIS X-RAY SYSTEM HAD A VESSEL MEASUREMENT ERROR (SIZE SELECTION) AND A TOO SMALL STENT WAS USED IN THE PROCEDURE. THE STENT HAD TO BE INFLATED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLURA XPER FD20 | IZI (SYSTEM, X-RAY ANGIOGRAPHIC) | IZI | PHILIPS MEDICAL SYSTEMS | 722006 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |