Events

CUTTING BALLOON PERIPHERAL - Registro ANVISA Nº 10341350358 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 INTERVENTIONAL TECHNOLOGIES EUROPE LIMITED, BOSTON SCIENTIFIC INTERNATIONAL B V, BOSTON SCIENTIFIC CORPORATION 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
    875
  • 날짜
    2006-12-12
  • 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 reports that the most important potential clinical effect related to balloon leakage is to prolong or delay the clinical procedure because of the need to change the balloon. The company also reports that although the likelihood of these failures is rare, they are possible, especially if the physician chooses to use the product in a different way from the Instructions for Use of the Product. The most serious damage expected from the outcome of this type of event is venous damage or an embolic event, which may result in the need for additional surgical procedures. The Anvisa Technovigilance unit is following up on this case. #### Update on 09/20/2007: The company Boston Ltda informed, in communication to Anvisa (file no. 242614/075, dated May 2, 2007) , that all affected products were collected (82 units, according to the company) and sent to the company's distribution center in the Netherlands for analysis. For further information, access alert no. 871.
  • 원인
    It has been found through analysis that the balloon may leak at the distal tip or otherwise there is the possibility of a failure to maintain the pressure. identified that this could be potential for the detachment of the arterotome or twisting of the folds of the balloon of the product.////// - see list of products affected (codes and lots) cutting balloon peripheral- let-2006-06-6364-fa , through the link: http: //www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2007/875.Pdf.
  • 조치
    1. Immediately discontinue use and segregate units affected by this action - Immediately remove all batches affected by this action from your inventory (and also from the Special Procedures Rooms, Interventional Radiology, OR, Hemodynamics, Central Service, Shipping, Receiving, or any other location). - Segregate the affected units in a safe place and return them to Boston Scientific of Brazil. The Company makes clear that the distribution or use of any remaining product affected by this Voluntary Product Medical Product Withdrawal must be terminated immediately. Replacement of these products is not available at the moment, however, a credit will be generated for all returned products. 2. Complete and return the Verification / Traceability Form - Complete the Verification / Traceability Form (even if you do not have any units to return), following the instructions on this page and the form itself. - Return all pages of the Verification / Traceability Form to BOSTON SCIENTIFIC DO BRASIL LTDA (11) 5502-8510 3. Packaging and Return of affected products - Pack the products to be returned in an appropriate box; - Identify the box with the customer's name; - Seal the carton and return it to Boston Scientific of Brazil:

Device

CUTTING BALLOON PERIPHERAL - Registro ANVISA Nº 10341350358

Manufacturer

INTERVENTIONAL TECHNOLOGIES EUROPE LIMITED, BOSTON SCIENTIFIC INTERNATIONAL B V, BOSTON SCIENTIFI...
  • Source
    ANVSANVISA