AUDIENCE: Risk Manager
ISSUE: Codman Neuro is informing physicians of this incorrect statement and updating the product's Instructions For Use (IFU). The product's IFU incorrectly noted: "A 2:1 (67% Ethiodized Oil / 33% nBCA) for feeding pedicle injections close to the nidus at high flow rates where venous opacification occurs on contrast injections within 1/2 second." The use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolization or reflux into arteries and pulmonary vessels. This could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.
The correct information should have stated: "A 2:1 (67% Ethiodized Oil / 33% nBCA) for Intranidal injections without AV fistulae or high flow rates in order to more deeply penetrate the nidus."
BACKGROUND: Trufill n-BCA is indicated for embolization of cerebral arteriovenous malformations (AVMs) when presurgical devascularization is desired. In October 2013, Codman Neuro identified an incorrect statement in the product's IFU that described suggested mixing ratios for use in certain treatment conditions.
Product is not being removed from the market. Trufill nBCA products associated with the correction notice were manufactured between February 25, 2010 and October, 31, 2013, distributed to hospitals and surgical centers, and include the following product codes (all lots): 631400 (Two 1 gram tubes nBCA) and 631500 (One 1 gram tube nBCA).
RECOMMENDATION: All customers who have purchased Trufill nBCA are reminded to review the correction notice and other product literature to ensure proper mixing procedures are followed. They may also call Codman Neuro with questions or to report any malfunction or adverse event on weekdays between the hours of 7:00am and 6:30pm Eastern Time at 1-866-491-0974, Option 2.
Health care providers and consumers may report adverse events or quality problems experienced with the use of any Main Street products to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.