FDA Adverse Event
Malfunction
Summary report: N
HALO 360 ABLATION CATHETER
MDR report key: 2213140
·
Received August 11, 2011
Report
- Report Number
- 2213140
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- July 21, 2011
- Report Date
- August 11, 2011
- Manufacturer
- BARRX MEDICAL, INC.
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
PT HERE FOR ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ABLATION OF BARRETT'S ESOPHAGUS. AFTER COMPLETION OF FIRST SET OF ABLATIONS, THE CATHETER WAS REMOVED. ABLATION CATHETER WAS CLEANED. THE ABLATION ZONE WAS CLEANED OF COAGULATIVE DEBRIS. THEN THE ABLATION CATHETER WAS RE-INTRODUCED. AT THIS TIME, THE CATHETER FAILED. CATHETER REMOVED FROM PATIENT AND WAS ASSESSED BY THE REPRESENTATIVE. THEN PROCEDURE WAS COMPLETED USING A NEW ABLATION CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HALO 360 ABLATION CATHETER | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | BARRX MEDICAL, INC. | 32041-25 | F1013351 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |