Events

IntellaTip Mifi XP Temperature Ablation Catheter 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
    2014-05-21
  • 사례 출판 날짜
    2014-05-21
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140521.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 intellatip mifi xp temperature ablation catheter medical device manufacturer, boston scientific, has issued a medical device safety alert concerning certain lots of the intellatip mifi xp temperature ablation catheter. the affected catalogue numbers are pm4500, pm4500k2, pm4500n4, pm4790, pm4790k2 and pm4790n4. an investigation has found that some of the units manufactured from 14 august 2013 to 16 january 2014 were not manufactured according to specification. although this issue will typically result in an error code on the maestro 3000 cadiac ablation system, under certain conditions or in the event of an error code override, this manufacturing issue may result in excessive radio frequency energy being delivered to the myocardium. to date, the manufacturer has received five complaints related to this issue and none of these complaints reported injury. the potential health hazards associated with the delivery of excessive radio frequency energy include myocardial perforation and cardiac tamponade, as well as char formation on the catheter tip, which may result in embolic injury. the manufacturer advises users not to use the affected products and these products should be returned. according to the local supplier, the affected products were not distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 may 2014.

Device

IntellaTip Mifi XP Temperature Ablation Catheter
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Boston Scientific IntellaTip Mifi XP Temperature Ablation Catheter
  • 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