Events

Pipeline Embolization Device (Pipeline Classic), Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire, UltraFlow HPC Flow Directed Microcatheter and Marathon Flow Directed Microcatheter 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
    2016-10-11
  • 사례 출판 날짜
    2016-10-11
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161011b.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 pipeline embolization device (pipeline classic), alligator retrieval device, xcelerator hydrophilic guidewire, ultraflow hpc flow directed microcatheter and marathon flow directed microcatheter the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning pipeline embolization device (pipeline classic), alligator retrieval device, xcelerator hydrophilic guidewire, ultraflow hpc flow directed microcatheter and marathon flow directed microcatheter manufactured by medtronic. all lot numbers that have a use by date between june 2017 and august 2019 are affected. for the pipeline embolization device, the issue only affects the delivery wire. the implant itself is not affected the manufacturer has identified the potential for an issue with a specific set of lot numbers of medtronic neurovascular products where the ptfe (polytetrafluoroethylene) coating could delaminate and separate from the delivery wire. through 27 september 2016, the manufacturer has received a total of five reports for the products that are potentially affected by this issue. the manufacturer has received no reports of serious injuries or patient death as a result of this issue. according to the manufacturer, delamination and detachment of the ptfe coating material may lead to ptfe coating in the blood stream. ptfe in the blood stream, depending on its specific size and quantity, could lead to thromboembolic complications or irreversible injuries including but not limited to: intracranial edema, peripheral edema, incomplete treatment, infection, local inflammatory response, systemic inflammatory response, ischemic stroke, lysis/necrosis, neurological deficit, organ impairment, shock, space occupying lesion, thrombosis, and hemorrhage. the manufacturer is recalling the affected products. customers are advised to quarantine and remove all unused affected products in their inventory. for affected product that has been used, no action is necessary and patients should continue to be managed in accordance with standard patient management protocol. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-3-7-october-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 october 2016.

Device

Pipeline Embolization Device (Pipeline Classic), Alligator Retrieval Device, Xcelerator Hydrophil...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Pipeline Embolization Device (Pipeline Classic), Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire, UltraFlow HPC Flow Directed Microcatheter and Marathon Flow Directed Microcatheter
  • 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