Events

PIPELINE EMBOLIZING DEVICE - Registration 80301610006 - MODELS / LOTS AFFECTED: VIDE ANNEX .. http://portal.anvisa.gov.br/wps/wcm/connect/f4094c804e37c340a02cb3c09d49251b/Lote_Afetados_no_Brasil.pdf?MOD=AJPERES 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 EV3 COMÉRCIO DE PRODUTOS ENDOVASCULARES DO BRASIL LTDA. 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 ID
    1224
  • 날짜
    2013-01-17
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    The company clarifies that such difficulties usually occur in patients with tortuous or restrictive anatomy. Therefore, patient selection and device use following the guidelines outlined in the Instructions for Use are critical. Anvisa follows this Field Action. See attached Customer Letter. http://portal.anvisa.gov.br/wps/wcm/connect/1b2139004e37c2c3a023b3c09d49251b/Carta_ao_Cliente.pdf?MOD=AJPERES####ERRORAMENTO - 03/12/2013 - The company forwards the Report of Completion of the Field Action, having communicated all its clients. ####
  • 원인
    The device may not readily disengage from the capture / protection coil and may not open completely and attach to the wall of the vessel. see attached customer letter. http://en.Wikipedia.Org/w/index.Php/.
  • 조치
    The company recommends to users that: If there is excessive friction during insertion of the supply system at any time during the use of the PED, carefully remove the whole system simultaneously (microcatheter and delivery system). See attached Customer Letter. http://en.wikipedia.org/w/index.php/

Device

PIPELINE EMBOLIZING DEVICE - Registration 80301610006 - MODELS / LOTS AFFECTED: VIDE ANNEX .. htt...

Manufacturer

EV3 COMÉRCIO DE PRODUTOS ENDOVASCULARES DO BRASIL LTDA.
  • 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
    ANVSANVISA