Events

Mitral Valve Repair System, MitraClip Clip Delivery System 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Abbott Vascular 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2013/013
  • 사례 연번
    CON249674
  • 날짜
    2013-03-19
  • 사례 출판 날짜
    2013-03-19
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON249674?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Risk of death or serious harm to the patient. if the actuator knob on the clip delivery system (cds) is turned in the wrong direction, this can prevent successful deployment of the clip, leading to the need for open surgical repair. the mhra has been notified by the manufacturer that there have been four reports (including one uk report), of the actuator knob of the clip delivery system (cds) being turned in the wrong direction (i.E. clockwise instead of anti-clockwise) when attempting to disengage and deploy the clip from the cds. turning the actuator knob incorrectly could lead to a fracture of the cds internal assembly, leading to an inability to control the release of the clip from the cds. since the clip may already have a firm grasp on the mitral valve at this point, open surgery may be required to disengage the clip from the cds. the uk incident led to the need for emergency open surgical repair. the bulk of the cds could only be removed from the clip using surgical bolt cutters and the remaining shaft of the cds unscrewed from the clip using forceps. unfortunately, the patient died one week later, following renal complications. in order to help prevent further incidents of this type, the manufacturer issued a fsn on 27 february 2013 providing advice. in addition, new devices will have a blue directional arrow on the actuator knob to help operators visualise the correct direction of turn. the manufacturer has also confirmed to the mhra that they intend to make a number of design changes which should ultimately make it impossible to turn the actuator knob in the wrong direction. the implementation of the final stages of the design changes will not, however, be completed for up to two years.
  • 조치
    Follow the manufacturer’s guidance given in the device’s Instructions for Use (IFU) and in their recent Field Safety Notice (FSN) with regards to the correct operation of the CDS Actuator Knob. Observe the blue arrow on the Actuator Knob, which is present on newer devices, indicating the direction in which it should be turned. Interventional Cardiologists Cardiothoracic Surgeons

Device

Mitral Valve Repair System, MitraClip Clip Delivery System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Mitral Valve Repair System. MitraClip Clip Delivery 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
    MHRA