Events

Safety Alert for MitraClip Clip Delivery System

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
    2016-02-04
  • Event Date Posted
    2016-02-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160204.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 mitraclip clip delivery system medical device manufacturer, abbott vascular, has issued a medical device safety alert concerning its mitraclip clip delivery system [product number: msk02st]. the system contains the clip delivery system [product number: cds02st] and the steerable guide catheter [product number: sgc01st]. the manufacturer has recently received nine reports of cases on clip delivery system devices that contain the one-way actuator knob [lot number 50714u1 and greater] where a user attempted implanting a mitraclip, but the clip could not be detached from the delivery system due to a mandrel fracture. these cases resulted in surgical interventions and, in one case; the patient expired post-operatively due to severe co-morbidities. the manufacturer’s investigation determined that a mandrel fracture may occur if tension is present on the mandrel when turning the actuator knob to deploy the clip. the tension is present if the arm positioner is on the “closed” side of neutral, as opposed to being in the neutral position during clip deployment. the manufacturer is revising the mitraclip ifu clip deployment sequence to provide additional assurance that tension is completely eliminated prior to deploying the clip. the manufacturer will train all mitraclip implanters on the revised instructions. there is no need to return any product to the manufacturer. 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 4 february 2016.

Device

MitraClip Clip Delivery System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Vascular MitraClip Clip Delivery System
  • 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