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Embolization System Has Incorrect Instructions; Class I Recall


The FDA has classified the recently initiated medical device correction notice related to the TRUFILL n-BCA Liquid Embolic System as a Class I recall.

 

TRUFILL n-BCA is indicated for embolization of cerebral arteriovenous malformations (AVMs) when presurgical devascularization is desired. An AVM is a rare condition in which tangles of abnormal blood vessels form in the arteries and veins of a person’s brain. Embolization, an alternative to open surgery, is a minimally invasive procedure involving the injection of a material or chemical into the AVM to block its blood supply, causing it to shrink.

 

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 manufacturer, Codman Neuro, identified an incorrect statement in the product's Instructions for Use (IFU) that described suggested mixing ratios for use in certain treatment conditions. 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 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." Codman Neuro issued a corresponding correction notice to inform customers in the U.S., Costa Rica, Puerto Rico, and Russia.

 

When the product is mixed correctly, it is expected to perform as intended. Thorough product training is required before purchasing the TRUFILL nBCA. The company has verified that all related physician training materials and promotional documents contain correct information.

 

TRUFILL nBCA products associated with the correction notice were manufactured between February 25, 2010, and October, 31, 2013. The products were distributed to hospitals and surgical centers.

 

The FDA has classified this recall as a Class I recall. These are the most serious type of recall involving situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the Recall

 

See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death

 

 

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