Events

Safety Alert for TRUFILL n-BCA Liquid Embolic System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Codman Neuro.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-01-23
  • Event Date Posted
    2014-01-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140123.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: codman neuro trufill n-bca liquid embolic system the united states food and drug administration (fda) has issued a medical device safety alert concerning trufill n-bca liquid embolic system [product code: 631400 & 631500], manufactured by codman neuro. according to the fda, trufill n-bca is indicated for embolization of cerebral arteriovenous malformations (avms) when presurgical devascularization is desired. in october 2013, the manufacturer identified an incorrect statement in the product's instructions for use (ifu) that described suggested mixing ratios for use in certain treatment conditions. the manufacturer is informing physicians of this incorrect statement and updating the product's 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 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." 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 advises all affected users to review the correction notice and other product literature to ensure proper mixing procedures are followed. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to fda websites:http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm382556.Htm http://www.Fda.Gov/safety/recalls/ucm382496.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 january 2014.

Device

TRUFILL n-BCA Liquid Embolic System
  • Model / Serial
  • Product Classification
    Neurological Devices
  • Product Description
    Medical Device Safety Alert: Codman Neuro TRUFILL n-BCA Liquid Embolic System
  • Manufacturer
    Codman Neuro

Manufacturer

Codman Neuro