Events

Trade name: POWERCROSS DILATATION CATHETER 0.018 OTW PTA Technical name: CATETER BALLOON FOR PERIPHERAL ANGIOPLASTY ANVISA Registration Number: 10349000474 Hazard Class: II Affected Model: AB18W030200150 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 AUTO SUTURE DO BRASIL LTDA; ev3 Inc. 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
    2120
  • 날짜
    2016-08-30
  • 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
    There is no need for action with the patient. Patients who received treatment with an OTW Dilatation Catheter for 0.018 "PowerCross ™ PTA affected by this recall should continue to be monitored according to standard practice.
  • 원인
    Auto suture is conducting a voluntary recall of two lots of otw dilatation catheter for pta powercross ™ 0.018 ". this recall was initiated for model ab18w030200150 and is limited to lot numbers a213373 and a216702. this voluntary recall is being initiated due to the identification of a divergence in the description of the size of the balloon. where these affected units, which have a true size of the 3 x 200 mm balloon, are incorrectly marked on the product itself, specifically in the area of ​​tension relief, such as 2.5 x 150 mm (as shown in the enclosed customer letter ). the correct labeling (3 x 200 mm) for the actual size of the balloon is included in the outer carton as well as the inner packaging of the affected devices.
  • 조치
    Field Action Code FA Recall PowerCross triggered under the responsibility of the company AUTO SUTURE DO BRASIL LTDA. Company will collect for further destruction.

Device

Trade name: POWERCROSS DILATATION CATHETER 0.018 OTW PTA Technical name: CATETER BALLOON FOR PERI...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; ev3 Inc.
  • 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