Events

Product: AMPHIRION DEEP OTW - PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. Anvisa registration No. 10339190532. Products affected: AMD015020002 AMD020120152 AMD025150152 AMD030150152 AMD040120002 AMD335210002 AMD015020151 AMD020150002 AMD030040002 AMD035040152 AMD040120152 AMD335210152 AMD015020152 AMD020150152 AMD030040152 AMD035120002 AMD040150002 AMD354210002 AMD020040002 AMD025040152 AMD030080002 AMD035150002 AMD040150152 AMD354210152. AMD020040152 AMD025080152 AMD030080152 AMD035150152 AMD225210002. AMD0200120002 AMD025120002 AMD030120002 AMD040040152 AMD225210152. AMD0200160152 AMD025120152 AMD030120152 AMD040080002 AMD253210002. AMD02012002 AMD025150002 AMD030150002 AMD040080152 AMD253210152 ... #### UPDATE (01/14/2016): According to the company, all the codes of the products affected globally were erroneously reported, but in Brazil only one code was affected (AMD225210152), of which only 03 lots are under risk - 209532760, 209507756 and 209507757. The above list (see above) does not therefore apply in its entirety to Brazil. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 MEDTRONIC COMERCIAL LTDA; INVATEC S.p.A. 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
    1749
  • 날짜
    2015-11-20
  • 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 potential for rupture in the pouch containing the sterilized product was discovered by Medtronic during in-house packaging testing, which involves exposure to extreme conditions of use. Rupture of the pouch seal may potentially result in compromised product sterility. Patients who received treatment with an Amphirion® Deep Catheter Dilatation Balloon for ATP affected by this recall should continue to be monitored according to their standard practice. #### UPDATED ON 7/24/2017, the company submitted the field action completion report proving the sending of the safety notice to the client and collection of the equipment informed.
  • 원인
    This recall was initiated because of a potential breach of the bag sealing for the products manufactured in these selected lots.
  • 조치
    The product is being collected by the company. Segregate the products in inventory, identifying them to avoid inadvertent use and contact the responsible company or distributor. Company code for the field action: FA684.

Device

Product: AMPHIRION DEEP OTW - PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. Anvisa regist...

Manufacturer

MEDTRONIC COMERCIAL LTDA; INVATEC S.p.A.
  • 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