Events

MitraClip System (Product Number # MSK02ST) containing the Clip Delivery System (Part number # CDS02ST) and the Steerable Guide Catheter (Part number # SGC01ST)(Used for reconstruction of the insufficient mitral valve through tissue approximation) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abbott Vascular Division of Abbott 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-00139-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-02-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00139-1
  • 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
    Abbott vascular has recently received nine reports of cases on clip delivery system devices that contain the one-way actuator knob (lot number 50714u1 and greater) where a user attempted implanting a mitraclip, but the clip could not be detached from the delivery system due to a mandrel fracture. these cases resulted in surgical interventions and, in one case; the patient expired post-operatively due to severe comorbidities.The mandrel is an internal component of the clip delivery system that is integral to clip function and deployment. abbott vascular’s investigation determined that a mandrel fracture may occur if tension is present on the mandrel when turning the actuator knob to deploy the clip. tension is present if the arm positioner is on the “closed” side of neutral, as opposed to being in the neutral position during clip deployment.
  • 조치
    While the current Instructions for Use (IFU) require the Arm Positioner to be in a Neutral position prior to turning the Actuator Knob to deploy the Clip, Abbott Vascular is revising the MitraClip IFU Clip deployment sequence to provide additional assurance that tension is completely eliminated prior to deploying the Clip. Abbott Vascular will train all MitraClip implanters on the revised instructions. The customer letter identifies what is changing in the IFU and explains the importance in eliminating tension during the delivery of the clip. Abbott Vascular is continuing to investigate the issue and working with the TGA to ascertain if any further actions need to be undertaken. This action has been closed-out on 17/05/2017.

Device

MitraClip System (Product Number # MSK02ST) containing the Clip Delivery System (Part number # CD...
  • 모델명 / 제조번호(시리얼번호)
    MitraClip System (Product Number # MSK02ST) containing the Clip Delivery System (Part number # CDS02ST) and the Steerable Guide Catheter (Part number # SGC01ST)(Used for reconstruction of the insufficient mitral valve through tissue approximation)Lot numbers: 50714U1 and higherARTG numbers:177709 and 189720
  • Manufacturer
    Abbott Vascular Division of Abbott Australasia Pty Ltd

Manufacturer

Abbott Vascular Division of Abbott Australasia Pty Ltd
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA