FDA Adverse Event
Injury
Summary report: N
VISUAL-ICE CRYOABLATION SYSTEM
MDR report key: 3104935
·
Received May 7, 2013
Report
- Report Number
- 3004462490-2013-00006
- Event Type
- Injury
- Date Received
- May 7, 2013
- Date of Event
- February 5, 2013
- Report Date
- April 12, 2013
- Manufacturer
- GALIL MEDICAL INC.
- Product Code
- GEH
- PMA / PMN Number
- K113860
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND NO MALFUNCTIONS OR ISSUES WITH THE DEVICE WERE REPORTED. THIS ADVERSE EVENT WAS COLLECTED AS PART OF A CLINICAL STUDY. PNEUMOTHORAX IS A KNOWN POTENTIAL ADVERSE EVENT FROM CRYOABLATION PROCEDURES AND IS DOCUMENTED AS SUCH IN THE PRODUCT IFU AND USER MANUAL. THE PT WAS TREATED AND THE ISSUE WAS RESOLVED.
Description of Event or Problem · 1
A LUNG ABLATION WAS CONDUCTED ON (B)(6) 2013. THE PT WAS DIAGNOSED WITH PNEUMOTHORAX, CTRCAE GRADE 2, ON (B)(6) 2013, REQUIRING A CHEST TUBE FOR 1 DAY. THE EVENT IS NOTED TO BE RELATED TO THE CRYOABLATION PROCEDURE AND IS A KNOWN POTENTIAL ADVERSE EVENT RELATED TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 198518 | VISUAL-ICE CRYOABLATION SYSTEM | CRYOSURGICAL UNIT, ACCESSORIES | GEH | GALIL MEDICAL INC. | FPRCH6000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |