FDA Adverse Event
Malfunction
Summary report: N
VISUAL ICE CRYOABLATION SYSTEM
MDR report key: 4088243
·
Received August 1, 2014
Report
- Report Number
- 3004462490-2014-00003
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Date of Event
- June 11, 2014
- Report Date
- July 3, 2014
- Manufacturer
- GALIL MEDICAL INC.
- Product Code
- GEH
- PMA / PMN Number
- K113860
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
(B)(6). EVENT OCCURRED DURING A LUNG ABLATION USING A SINGLE ICESPHERE NEEDLE. AT APPROXIMATELY 5 MINUTES DURING THE THIRD FREEZE, THE PHYSICIAN NOTICED THERE WAS LITTLE ICE ON THE NEEDLE HANDLE AND CABLING AS COMPARED TO THE FIRST AND SECOND FREEZE CYCLES. AROUND 8 MINUTES, THE GAS FLOW WAS INTERRUPTED. THE PRESSURE ON THE GAS CYLINDER WAS REPORTED TO BE CORRECT BY HOSPITAL STAFF. ABLATION ZONE SUSPECTED TO BE INSUFFICIENT. FOLLOW UP IMAGING PER STUDY PROTOCOL WILL DETERMINE IF THE PROCEDURE WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451874 | VISUAL ICE CRYOABLATION SYSTEM | CRYOSURGICAL DEVICES AND ACCESSORIES | GEH | GALIL MEDICAL INC. | FPRCH6000 | B3701-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |