FDA Adverse Event
Other
Summary report: N
FOGARTY ARTERIAL EMBOLECTOMY CATHETER
MDR report key: 515236
·
Received March 4, 2004
Report
- Report Number
- 6000002-2004-00035
- Event Type
- Other
- Date Received
- March 4, 2004
- Date of Event
- February 7, 2004
- Report Date
- February 7, 2004
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DXE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A BALLOON SEPARATION OCCURRED ON SECOND EXTRACTION. STRONG RESISTANCE WAS FELT WHEN THE CATHETER PASSED FEMORAL ARTERY ANASTOMOSIS. TWO CATHETERS WERE USED AFTER THE EVENT TO CONTINUE EMBOLECTOMY AND EXTRACTION OF THE DETACHED BALLOON, ONLY THE EMBOLECTOMY WAS SUCCESSFUL AND DETACHED BALLOON WAS NEVER RECOVERED. NO PT COMPLICATIONS WERE REPORTED. THE RESISTENCE IS DESCRIBED BY CUSTOMER AS BEING CONTRIBUTED TO CALCIFICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER | EMBOLECTOMY CATHETER | DXE | EDWARDS LIFESCIENCES | 120804F | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |