Events

Archer 0.035 inch (0.89mm) Super Stiff Guidewire 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic Inc. 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
    2013-03-22
  • 사례 출판 날짜
    2013-03-22
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130322a.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 archer 0.035 inch (0.89mm) super stiff guidewire medical device manufacturer,medtronic inc., has initiated a medical device field safety correction action concerning specific lot numbers of the medtronic archer 0.035 inch (0.89mm) super stiff guidewire, models arcsj200w, arcsj260w and arcdj260w. medtronic has identified an issue involving the affected products, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use. as a result, medtronicis recalling the affected guidewires. as of 1 feb, 2013, medtronic has received 9 reports involving 14 guidewires related to this issue; 4 of these reports involved serious injury.There were no patient deaths and no additional reported clinical sequelae related to these reports. in hong kong, the local supplierhas not been aware of any adverse incident related to the above mentioned issue. based on these reports, the overall failure rate of affected guidewires is approximately 0.1% for the kinking or breaking in-vivo.Corrective actions to the manufacturing process have been taken to prevent recurrenceof this issue in subsequent production. the manufacturer advises that patients should continue to be managed in accordance with the standard patient management protocol andthe guidewireinstruction foruse. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 march 2013.

Device

Archer 0.035 inch (0.89mm) Super Stiff Guidewire
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • 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