Events

Zilver PTX Drug-Eluting Peripheral Stent 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2013-RN-00359-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-04-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00359-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Cook medical has received a number of complaint reports relating to the delivery system for the zilver ptx drug eluting stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section. this recall follows from a previous recall for product correction rc-2012-rn-01282-1.
  • 조치
    Cook Medical is initiating the recall of Zilver PTX devices since there is a higher than expected potential of inner delivery catheter breakage due to inconsistencies in the catheter manufacturing process. The recall is intended to address the patient risks that may be associated with the potential failure mode.

Device

Zilver PTX Drug-Eluting Peripheral Stent

Manufacturer

William A Cook Australia Pty Ltd