Events

Safety Alert for Left Atrial Appendage Closure System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Boston Scientific Corporation.

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
  • Event ID
    R1604-149
  • Event Number
    2010DM-0007757
  • Date
    2016-04-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=147
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer informs that he has received reports of embolization of the implant during the procedure as well as after it, leading to the occurrence of adverse events on the patients.

Device

Left Atrial Appendage Closure System
  • Model / Serial
    WATCHMAN FLX / WS5020, WS5024, WS5027, WS5031 and WS5035, specific batches.
  • Product Description
    The closure technology of the left atrial appendage WATCHMAN was designed to avoid embolization of the atrial appendage of the left atrial appendage and reduce the risk of life-threatening hemorrhage in nonvalvular atrial confibrillation patients who are suitable for anticoagulant treatment or who present a contraindication for anticoagulant treatment. of instructions for use: reinforcing the existing instructions for use to offer greater guidance regarding the correct use of the hemostasis valve to avoid coiling and to securely seal the valve. Minimizing the possibility of undesirable blood leakage, which could prevent potentially adverse events from occurring. the patient.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 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
    NIDFSINVIMA