Device product
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.
Z-0789-2014
Product summary
- Event
- Event 66493
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7,983
- Official record key
device-enforcement:Z-0789-2014
Official wording
Reason: Incorrect instructions for use (IFU).
Code information: All lot codes
Distribution pattern: Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
Derived failure modes
-
Unknown
Incorrect instructions for use (IFU).