Device product
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
Z-2256-2018
Product summary
- Event
- Event 80180
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57 units
- Official record key
device-enforcement:Z-2256-2018
Official wording
Reason: The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.
Code information: Lot Codes: 02132018-01 & 02162018-03
Distribution pattern: Distribution US nationwide.
Derived failure modes
-
Unknown
The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.