Events

FlexCath Advance Steerable Sheath 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 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
  • 날짜
    2017-10-12
  • 사례 출판 날짜
    2017-10-12
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171012.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medtronic flexcath advance steerable sheath medical device manufacturer, medtronic, has issued a medical device safety alert concerning its flexcath advance steerable sheath (model number 4fc12). the manufacturer is informing customers regarding an update to the abovementioned product’s instructions for use (ifu) manual. this ifu revision incorporates current best practices for minimizing the potential for air ingress and the risk of air embolism. this ifu update is not in response to a device design deficiency, device malfunction, or a change in reported field performance data. air embolism is a known risk for patients undergoing percutaneous interventions requiring access to the left atrium, such as ablation procedures. according to the 2017 hrs/ehra/ecas/aphrs/solaece expert consensus statement on catheter and surgical ablation of atrial fibrillation, “the most common cause of air embolism is introduction of air via the transseptal sheath.” the manufacturer has supplemented 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, and with recommendations from hrs, jhrs, and ehra. users are advised to review the ifu update summary regarding air ingress and air embolism provided by the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 october 2017.

Device

FlexCath Advance Steerable Sheath
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic FLexCath Advance Steerable Sheath
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH