Events

Lotus Valve System 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Boston Scientific 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
    2016-08-04
  • 사례 출판 날짜
    2016-08-04
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160804a.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: boston scientific lotus valve system medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its lotus valve system [upn: h749ltv230, h749ltv250, h749ltv270, h749ltvr3cl230, h749ltvr3cl250, h749ltvr3cl270]. the manufacturer is implementing a voluntary fsca for the lotus valve system to remove units from the field that were manufactured prior to a component related change made in march 2016. products manufactured after the implementation of this change are not impacted. there is no additional safety issue for patients who previously received a lotus implant since the issue only involves the delivery system and is not related to the performance of the implanted valve. according to the manufacturer, this action is related to a release mandrel breaks. the release mandrel is a component of the delivery system that is connected to the release pin which facilitates release of the valve from the delivery system. the manufacturer has not received any reports of release mandrel breaks for units built after the component change in march 2016. there was a number of release mandrel breaks reported for product manufactured prior to the component change. the most common outcome was resheating and removing the device without difficulty, resulting in procedural prolongation. however, the most severe outcome was catastrophic vessel trauma associated with patient death, which was reported in three cases. the manufacturer is now taking action to remove all units from the field that were manufactured prior to the change. the affected users are instructed to quarantine the affected products. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 august 2016.

Device

Lotus Valve System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Boston Scientific Lotus Valve System
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH