Events

Safety Alert for Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheter and MONORAIL PTA Balloon Dilatation Catheter

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

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
    2014-02-06
  • Event Date Posted
    2014-02-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140206.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: boston scientific coyote over-the-wire pta balloon dilatation catheter and monorail pta balloon dilatation catheter medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its coyote over-the-wire pta balloon dilatation catheter and monorail pta balloon dilatation catheter. the manufacturer is initiating a recall removal of one lot of the coyote over-the-wire pta balloon dilatation catheter [catalog no.: 39186-25121; lot 16397693] and one lot of the coyote monorail pta balloon dilatation catheter [catalog no.: 39185-20151; lot 16310947]. the manufacturer has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. to date, the manufacturer has received three complaints for this issue. according to the manufacturer, the most common adverse health consequences resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention. the manufacturer instructs all affected users to cease immediately further distribution or use of any remaining product affected by this medical device safety alert. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 february 2014.

Device

Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheter and MONORAIL PTA Balloon Dilatation Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheter and MONORAIL PTA Balloon Dilatation Catheter
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH