Events

MitraClip Mitral Valve Repair System 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Abbott Vascular 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2013-02-28
  • 사례 출판 날짜
    2013-02-28
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130228.html
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: abbott mitraclip mitral valve repair system medical device manufacturer, abbott vascular, has issued a field safety notice concerning mitraclip mitral valve repair system (product number msk02st). abbott vascular has received a total of 4 reports since 2008 where the actuator knob of the clip delivery system was incorrectly turned in the clockwise direction during clip deployment. in the event that the actuator knob is incorrectly turned, the device may incur damage that prevents the deployment of the clip. additional medical intervention or conversion to surgery may then be required. the current inventory of product is acceptable for safe use following the steps highlighted in the instructions for use (ifu). patients that have had clips successfully implanted are not affected by this action. the manufacturer advises all users to consult the approved ifu that were distributed with each device, which contains important information for the proper clip deployment steps. specifically, step 17.2.2 states: “turn the actuator knob of the dc approximately 8 turns counterclockwise. if it is difficult to turn the actuator knob, confirm that the arm positioner moves freely. retract the actuator knob after it is fully unthreaded.” subsequent to this step, the following warning appears: “failure to stop turning the actuator knob when resistance is felt or turning the actuator knob in the clockwise direction may result in inability to deploy the clip.” furthermore, the manufacturer will add a directional arrow on the actuator knob of newly manufactured devices to aid in proper clip deployment. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 february 2013.

Device

MitraClip Mitral Valve Repair System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Abbott MitraClip Mitral Valve Repair System
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “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