Events

ARRIVE Braided Transseptal Sheath 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-01432-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-11-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01432-1
  • 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
    Medtronic was recently notified that the manufacturer, oscor has initiated a product recall for certain lots of their adelante breezeway 8f & 10f sheaths due to a potential for "a fragment of the sheath inner liner to come off during the insertion of the dilator during the preparation of the sheath prior to use." medtronic sells the oscor adelante breezeway 10f product as the arrive braided transseptal sheath. oscor has received one complaint related to this issue, which did not result in patient injury. however, the risk for possible injury is a concern if the sheath is not properly flushed and tested with the dilator prior to use.
  • 조치
    Customers are advised to immediately quarantine and return all affected stock. Medtronic Customer Service Representative will organise the return and replacement of unused products. For affected product that has been used, no action is necessary and patients should continue to be managed in accordance with the standard patient management protocol.

Device

ARRIVE Braided Transseptal Sheath
  • 모델명 / 제조번호(시리얼번호)
    ARRIVE Braided Transseptal Sheath Model Numbers: 990061-055, 990061-070, 990061-090, 990061-120, 990079-055, 990079-070, 990079-090Multiple Lot NumbersARTG Number: 202067
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA