Events

Pipeline Flex, Marathon Flow Directed Micro Catheter, Alligator Retrieval Device, Pipeline Embolization Device 의 안전성 경고

National Drugs Administration from El Salvador (DNM)에 따르면, 해당 안전성 경고 는 El Salvador 에서 Medtronic 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
  • 사례 위험등급
    Class I
  • 날짜
    2016-12-01
  • 사례 국가
    El Salvador
  • 사례 출처
    DNM
  • 사례 출처 URL
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • 비고 / 경고
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
  • 데이터 추가 비고
  • 원인
    The cause of the alert is related to the detachment of the polytetrafluoroethylene (ptfe) coating, which serves to reduce friction between devices and facilitate navigation through the vasculature. the delamination of the layer could possibly lead to an embolic occlusion in the cerebral tilt with the risk of a spill and / or death.
  • 조치
    Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment. - Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices

Device

Pipeline Flex, Marathon Flow Directed Micro Catheter, Alligator Retrieval Device, Pipeline Emboli...
  • 모델명 / 제조번호(시리얼번호)
    Sanitary DNM Registration Numbers: IM079130062016, IM031905032015, IM026307042016. PIM number:882014
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NDAESDNM