Events

RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation Device 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
    2015-10-16
  • 사례 출판 날짜
    2015-10-16
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151016c.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 rotawire elite guidewire and wireclip torquer guidewire manipulation device medical device manufacturer, boston scientific, has issued a field safety notice regarding the rotawire elite guidewire and wireclip torquer guidewire manipulation device that is used in conjunction with the rotablator rotational atherectomy system. the affected material numbers, batch numbers and batch expiration date range are shown below: material number (batch number): h802223301, h802223300 (18201519, 18212726, 18256610, 18261218, 18271412, 18282032, 19362094, 18378161, 18379210, 18384443) h802233301 and h802233300 (18141187, 18194620, 18220238, 18261834, 18285502, 18303265, 18390089) batch expiration date range: 25 june 2017 through 9 september 2017 the manufacturer has received three complaints for wire fracture. one fracture occurred during device prep, and the other two fractures occurred during the procedure resulting in burr migration into the pericardium. one of these involved placement of a covered stent to address vessel perforation. that patient subsequently expired. the other required surgery for removal of the fragment. product recall is on-going. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 16 october 2015.

Device

RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation Device
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 제품 설명
    Medical Device Safety Alert: Boston Scientific RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation Device"
  • 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