Events

Lotus Valve System (transcatheter aortic valve implantation (TAVI) system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Boston Scientific 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-2016-RN-01016-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-08-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01016-1
  • 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
    Boston scientific is undertaking a recall of the lotus valve system to remove units from the field that were manufactured prior to a component related change made in march 2016. this action is related to release mandrel breaks. the release mandrel is a component of the delivery system that is connected to the release pin which facilitates release of the valve from the delivery system.Products manufactured after the implementation of the component change are not impacted. boston scientific has not received any reports of release mandrel breaks for units built after this change. there is no impact to previously implanted devices since the issue only involves the delivery system and is not related to the performance of the implanted valve.
  • 조치
    Boston Scientific is advising users to immediately discontinue use of and segregate affected product. Boston Scientific will arrange for the return of affected product. This action has been closedd-out on 16/02/2017.

Device

Lotus Valve System (transcatheter aortic valve implantation (TAVI) system)
  • 모델명 / 제조번호(시리얼번호)
    Lotus Valve System (transcatheter aortic valve implantation (TAVI) system) Product numbers : H749LTV230, H749LTV250, H749LTV270Affected lot numbers remaining in the market : 18948721, 18948723, 18948521ARTG Number: 260448
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA