FDA Adverse Event
Injury
Summary report: N
CRYOSPRAY ABLATION SYSTEM
MDR report key: 1735711
·
Received June 17, 2010
Report
- Report Number
- 3004534508-2010-00003
- Event Type
- Injury
- Date Received
- June 17, 2010
- Date of Event
- June 1, 2009
- Report Date
- June 17, 2010
- Manufacturer
- CSA MEDICAL, INC.
- Product Code
- GEH
- PMA / PMN Number
- K060555
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADVERSE EVENT WAS DISCOVERED THROUGH A PUBLISHED ABSTRACT. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. AS OF 17-JUN-2010, THE PHYSICIAN/INSTITUTION HAS ONLY CONFIRMED THAT THE ADVERSE EVENT OCCURRED BETWEEN (B)(6)-(B)(6) 2009. A CSA MEDICAL SERVICE REPRESENTATIVE EVALUATED THE CONSOLE AND FOUND IT TO BE OPERATING WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
PATIENT EXPERIENCED A PNEUMOTHORAX DURING CRYOSPRAY TREATMENT. PHYSICIAN/INSTITUTION HAS NOT PROVIDED ADDITIONAL INFORMATION TO COMPANY AS OF 06/17/2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYOSPRAY ABLATION SYSTEM | CRYOSPRAY | GEH | CSA MEDICAL, INC. | CC2-NAM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |