FDA Adverse Event
Malfunction
Summary report: N
FOGARTY EMBOLECTOMY CATHETER
MDR report key: 1972183
·
Received January 17, 2011
Report
- Report Number
- 1972183
- Event Type
- Malfunction
- Date Received
- January 17, 2011
- Date of Event
- December 14, 2010
- Report Date
- January 17, 2011
- Manufacturer
- EDWARD LIFESCIENCE
- Product Code
- DXE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT, US
Narratives
Description of Event or Problem · 1
DURING A REPAIR OF CERVICAL H-TYPE TRACHEOESOPHAGEAL FISTULA, THE FOGARTY CATHETER, WHICH HAD BEEN PLACED AT THE BEGINNING OF THE OPERATION TO THE FISTULOUS TRACT HAD BECOME DISLODGED. THE PHYSICAN ELECTED TO COVER THE OPEN WOUND AND REPEAT THE BRONCHOSCOPY FOR REPLACEMENT OF A FOGARTY CATHETER. THE WOUND WAS COVERED WITH IOBAN DRESSING. A RIGID BRONCHOSCOPY WAS THEN REPEATED. THERE WERE TWO (2) SMALL FRAGMENTS OF THE BALLOON WITHIN THE TRACHEA, WHICH WERE REMOVED USING THE SUCTION DEVICE. THE TRACHEA WAS THEN CLEARED OF DEBRIS. A #4 FOGARTY CATHETER WAS THEN REPASSED THROUGH THE FISTULOUS TRACT. THE BALLOON INFLATED.HEALTH PROFESSIONAL'S IMPRESSION: BALLOON FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOGARTY EMBOLECTOMY CATHETER | CATHETER, EMBOLECTOMY | DXE | EDWARD LIFESCIENCE | * | F3628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO |