Events

FlexCath Advance Steerable Sheath(Medtronic Australasia Pty Ltd - FlexCath Advance 4FC12 - Catheter introducer, haemostasis valve) 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-2017-RN-01290-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-10-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01290-1
  • 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 is advising of an update to the medtronic flexcath advance steerable sheath, instructions for use (ifu). this ifu revision incorporates current best practices for minimising the potential for air ingress and the risk of air embolism.The ifu update includes additional language emphasising minimisation of catheter exchanges, proper aspiration and flushing techniques, and slow advancement and withdrawal of catheters through the sheath.There are no changes to the management of patients who have been or will be ablated with a system using a flexcath advance steerable sheath. it continues to perform as expected in relation to the potential for haemostatic valve leak. this failure mode is monitored and the occurrence rate has been stable over time. as of 31-august-2017, 79 reports of adverse events have been reported out of more than 255,800 devices distributed worldwide. one catastrophic event, associated with death, may have been related to this issue.
  • 조치
    Medtronic is providing users with a supplement the FlexCath Advance Steerable Sheath IFU to highlight the known risk of air embolism more prominently. These updates do not impact current clinical practice as this information is consistent with current training and education materials.

Device

FlexCath Advance Steerable Sheath(Medtronic Australasia Pty Ltd - FlexCath Advance 4FC12 - Cathet...
  • 모델명 / 제조번호(시리얼번호)
    FlexCath Advance Steerable Sheath(Medtronic Australasia Pty Ltd - FlexCath Advance 4FC12 - Catheter introducer, haemostasis valve)Model Number: 4FC12All Lot NumbersARTG Number: 213965
  • 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