Events

Safety Alert for NC Trek RX Coronary Dilatation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter

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

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
    2017-03-22
  • Event Date Posted
    2017-03-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170322a.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: abbott vascular nc trek rx coronary dilatation catheter, nc traveler rx coronary dilatation catheter, and nc tenku rx ptca balloon catheter william cook europe has issued a medical device safety alert concerning its zenith alpha thoracic endovascular graft (zta-). [catalog numbers: zta-d-28-160, zta-d-28-229, zta-d-30-160, zta-d-30-229, zta-d-32-160, zta-d-32-229, zta-d-34-142, zta-d-34-190, zta-d-36-142, zta-d-36-190, zta-d-38-147, zta-d-38-197, zta-d-40-147, zta-d-40-197, zta-d-42-152, zta-d-42-204, zta-d-44-157, zta-d-44-211, zta-d-46-157, zta-d-46-211, zta-de-18-104, zta-de-18-148, zta-de-20-104, zta-de-20-148, zta-de-22-104, zta-de-22-148, zta-de-24-104, zta-de-24-148, zta-de-26-104, zta-de-26-148, zta-de-28-108, zta-de-28-154, zta-de-30-108, zta-de-30-154, zta-de-32-108, zta-de-32-154, zta-de-34-112, zta-de-34-160, zta-de-36-112, zta-de-36-160, zta-de-38-141, zta-de-38-91, zta-de-40,-141 zta-de-40-91, zta-de-42-146, zta-de-42-94, zta-de-44-151, zta-de-44-97, zta-de-46-151] the safety communication is to call the attention to several aspects of the new version of the instructions for use (ifu) for the zenith alpha thoracic endovascular graft. the updates are of key importance when using the device to treat blunt thoracic aortic injury (btai), which is covered under the newly approved indication for isolated lesions of the descending thoracic aorta. the clinical trial patients with thrombus tended to have smaller graft diameters and greater oversizing on average than the patients without thrombus. similar trends were observed among the commercial reports as well, with those patients also tending to have a small aortic arch radius of curvature. additionally, while approximately 50% of the clinical trial patients had an aortic diameter that tapered from large proximally to small distally (by at least 10%), a tapered graft was not consistently used (20% received a tapered graft). according to the manufacturer, the field safety notice is for information purposes. no devices need to be returned, and patients already treated for btai should be followed in accordance with the current ifu, since follow-up has not been amended. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 march 2017.

Device

NC Trek RX Coronary Dilatation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenk...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Vascular NC Trek RX Coronary Dilatation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH