FDA Adverse Event
Malfunction
Summary report: N
FOGARTY ARTERIAL EMBOLECTOMY CATHETER
MDR report key: 160017
·
Received March 26, 1998
Report
- Report Number
- 6000002-1998-00059
- Event Type
- Malfunction
- Date Received
- March 26, 1998
- Date of Event
- February 21, 1998
- Manufacturer
- BAXTER HEALTHCARE INC.
- Product Code
- DXE
- Report Source
- Manufacturer report
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
BALLOON FROM FOGARTY CATHETER WAS MISSING AFTER CATHETER WAS USED ON PATIENT. NO PATIENT ISSUES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER | EMBOLECTOMY CATHETER | DXE | BAXTER HEALTHCARE INC. | 12-080-4F | 517L8668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |