FDA Adverse Event
Malfunction
Summary report: N
ATS CRYOMAZE SYSTEM
MDR report key: 1314064
·
Received January 22, 2009
Report
- Report Number
- 1314064
- Event Type
- Malfunction
- Date Received
- January 22, 2009
- Date of Event
- January 21, 2009
- Report Date
- January 22, 2009
- Manufacturer
- ATS MEDICAL INC.
- Product Code
- NFC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT, US
Narratives
Description of Event or Problem · 1
THE ATS CRYOMAZE CLAMP WOULD NOT WORK, THE CRYO UNIT WOULD NEVER ENGAGE. A SECOND PACKAGE WAS OPENED TO BEGIN AND COMPLETE PROCEDURE.MANUFACTURER PROVIDED (B)(4) FOR RETURN PRODUCT EVALUATION.
Description of Event or Problem · 1
THE ATS CRYOMAZE CLAMP WOULD NOT WORK, THE CRYO UNIT WOULD NEVER ENGAGE. A SECOND PACKAGE WAS OPENED TO BEGIN AND COMPLETE PROCEDURE.MANUFACTURER PROVIDED RGA FOR RETURN PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATS CRYOMAZE SYSTEM | PROBE, CRYO ABLATION | NFC | ATS MEDICAL INC. | 60CM1 | 50029400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |