Events

Safety Alert for Relay and Relay NBS Thoracic Stent-Graft Systems

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

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
    2014-08-12
  • Event Date Posted
    2014-08-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140812c.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: bolton medical relay and relay nbs thoracic stent-graft systems medical device manufacturer, bolton medical, has issued a field safety notice (fsn) concerning its relay and relay nbs thoracic stent-graft systems with the following information: references: 28m3###########x and 28n2###########x all lots manufactured prior to august 2014 according to the fsn, it has been observed in a small number of cases that the inner secondary sheath may not fully exit the outer primary sheath upon reaching the black line. in this situation, the distal end of the stent-graft will also remain within the outer primary sheath. failure to recognize this condition prior to deployment can lead to deployment difficulty or deployment failure. there is no impact on devices already implanted. the manufacturer is recommending the following additional verification steps prior to proceeding to the final stent-graft positioning and deployment: 1) upon reaching the intended proximal landing zone, visually confirm that the distal stent marker bands can be seen approximately 2cm outside of the outer primary sheath. 2) if the distal stent marker bands do not appear to have exited the outer primary sheath, while in position 1, hold the gray deployment grip stationary while pulling back on the black stationary grip until the distal stent marker bands have exited the outer primary sheath by approximately 2cm. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 12 aug 2014.

Device

Relay and Relay NBS Thoracic Stent-Graft Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bolton Medical Relay and Relay NBS Thoracic Stent-Graft Systems
  • Manufacturer
    Bolton Medical

Manufacturer

Bolton Medical