Events

Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire and Marathon Microcatheter (with Stylet) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Covidien 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-01319-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-10-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01319-1
  • 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 has identified the potential for an issue with a specific set of lot numbers of medtronic neurovascular products where the ptfe (polytetrafluoroethylene) coating could de-laminate and separate from the delivery wire. de-lamination and detachment of the ptfe coating material may lead to ptfe coating in the blood stream. ptfe in the blood stream, based on its specific size and quantity could lead to thromboembolic complications or irreversible injuries including but not limited to: intracranial oedema, peripheral oedema, incomplete treatment, infection, local inflammatory response, systemic inflammatory response, ischemic stroke, lysis/necrosis, neurological deficit, organ impairment, shock, space occupying lesion, thrombosis, and haemorrhage.Through september 27 2016, medtronic has received a total of five (5) reports for the products that are potentially affected by this issue however; no reports of serious injuries or patient death have been reported.
  • 조치
    Customers are advised to quarantine and remove all unused affected products in their inventory. Medtronic will be issuing a credit for the returned, unused and unexpired device(s). If replacement product is needed, Medtronic representative can assist customers with identifying suitable replacement products. For affected product that has been used, no action is necessary and patients should continue to be managed in accordance with your standard patient management protocol.

Device

Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire and Marathon Microcatheter (with Sty...
  • 모델명 / 제조번호(시리얼번호)
    Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire and Marathon Microcatheter (with Stylet)Multiple Catalogue and Lot numbersManufactured between August 2014 and September 2016ARTG Numbers: 190843, 203671, 274595
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien 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