FDA Adverse Event
Other
Summary report: N
HALO90 ABLATION CATHETER
MDR report key: 1340329
·
Received March 4, 2009
Report
- Report Number
- 3004904811-2009-00009
- Event Type
- Other
- Date Received
- March 4, 2009
- Date of Event
- October 2, 2008
- Report Date
- January 21, 2009
- Manufacturer
- BARRX MEDICAL, INCORPORATED
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PT WITH 10 CM OF HGD. NODULARITY RESECTED FOR STAGING WITH EMR. ALTHOUGH A STRICTURE RELATED TO EMR WAS NOT REPORTED, FOCAL ABLATION, RATHER THAN CIRCUMFERENTIAL ABLATION, WAS PERFORMED AFTER EMR HEALED, SUGGESTING ESOPHAGEAL NARROWING. PT THEN DEVELOPED FURTHER NARROWING WHICH WAS DILATED SERIALLY. NO FOLLOW-UP REGARDING RESOLUTION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HALO90 ABLATION CATHETER | COAGULATION CATHETER | GEI | BARRX MEDICAL, INCORPORATED | NOT PROVIDED | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |