Events

Wallstent Tips Endoprosthesis with Unistep Release System (WALLSTENT® Carotid with Monorail® Delivery System), ANVISA registration no. 10341350226. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Boston Scientific 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
    834
  • 날짜
    2006-07-17
  • 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
    According to Boston Scientific, so far, it has received no reports of complications or damage associated with this product disability. In addition to the batches reported in this notification, this recall does not affect any other WALLSTENT® Carotid with Monorail® Delivery System. The Unit of Technovigilance - UTVIG / NUVIG / ANVISA is monitoring the actions of the company. Voluntary Withdrawal Notification Letter: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/834_recall.pdf Verification / Traceability Form to be completed by affected clients: http://www.anvisa.gov. br / technovigilance / alerts / annexes_2006 / 834_formula.pdf
  • 원인
    As of 06/29/2006, boston scientific has received 26 claims related to the inability to irrigate the product release system at the time of rescue. the potential clinical effects associated with this complication include prolongation and delay of the clinical procedure.
  • 조치
    Immediately discontinue use and segregate the units affected by this recall (the attached table provides a complete list of products affected by this recall, including codes, batch numbers, and product descriptions). List of affected products: The distribution or use of products affected by this recall must cease immediately. Corrective measures are being implemented and the replacement of the product is now available. ************************************************ Update on 08/15/2006: Boston Scientific informs that all customers have already been notified and that all affected products have already been collected. In total, 646 units of affected products were collected. http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/834_prod_afetados.pdf

Device

Wallstent Tips Endoprosthesis with Unistep Release System (WALLSTENT® Carotid with Monorail® Deli...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA