Events

Safety Alert for JETSTREAM Atherectomy Catheters

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
    2017-04-18
  • Event Date Posted
    2017-04-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170418b.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 jetstream atherectomy catheters medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its jetstream atherectomy catheters. the manufacturer is initiating a voluntary removal of two lots of jetstream sc 1.85mm [material numbers: 112262-001, 112262-003; lot numbers: 18775553, 18775552; expiration date: 24 december 2017] and one lot of jetstream xc 2.1mm [material number: 112264-001; lot number: 18822086; expiration date: 24 december 2017] atherectomy catheters due to these units being mislabeled. some 1.85mm jetstream sc catheters may have been labeled as 2.1mm catheters, and some 2.1mm jetstream xc catheters may have been labeled as 1.85mm catheters. the affected units that were distributed between january and september 2016 are labeled as bayer product. according to the manufacturer, the most reasonably foreseeable consequence of this situation would be an insignificant prolongation of the procedure to exchange the device for another. there have been no reported patient adverse events as a result of this issue. the affected users are advised to immediately remove all affected products from their inventory (whether in central service, shipping and receiving, or any other location) and segregate the affected products in a secure location for return to the manufacturer. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 april 2017.

Device

JETSTREAM Atherectomy Catheters
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific JETSTREAM Atherectomy Catheters
  • 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