Events

ACUITY Pro Coronary Sinus 9Fr Outer Guide Catheters 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
    2015-11-30
  • 사례 출판 날짜
    2015-11-30
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151130b.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: acuity pro coronary sinus 9fr outer guide catheters medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its acuity pro coronary sinus 9fr outer guide catheters. [product model: 8104 – 8119, lot number: multiple] the acuity pro 9fr guide catheter is designed to provide a pathway into the coronary venous system for implantation of a left ventricular pacing lead. the catheter has a proximal handle with an integrated hemostasis valve and a shaft with a flexible distal segment. once the left ventricular lead is placed, the handle and distal segment are cut and removed. the manufacturer has received reports of handle separations during the cut and removal process; there have been no reported patient harms. after full investigation, the manufacturer concludes that if the hub and shaft are aligned off-centre in the bonding equipment during manufacturing; the result may be a reduced bond, which may separate during cutting. the affected product lots were manufactured during the period when the equipment was likely to be misaligned. product recall is ongoing. according to the local supplier, the affected lots are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 november 2015.

Device

ACUITY Pro Coronary Sinus 9Fr Outer Guide Catheters
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: ACUITY Pro Coronary Sinus 9Fr Outer Guide Catheters
  • 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