Events

Thermocool SmartTouch Bi-Directional Navigation Catheter and Thermocool SmartTouch Uni-Directional Navigation Catheter (used to facilitate electrophysiological mapping of the heart and to undertake RF ablations) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2013-RN-00965-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-09-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00965-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Customer complaints reported that the smarttouch catheters were not irrigating correctly during ablation and often resulted in temperature increases and generator shut-off. an internal investigation identified that there is polyimide delamination of the inner lumen surface that can lead to occlusion of the irrigation fluid lumen. insufficient or lack of irrigation (occlusion) can potentially increase the risk of char or thrombus formation at the tip of ablation catheter, which may lead to thromboembolic events, such as stroke.
  • 조치
    Customers are asked to quarantine the affected product remaining in the market and return it to Johnson & Johnson Medical Pty Ltd.

Device

Thermocool SmartTouch Bi-Directional Navigation Catheter and Thermocool SmartTouch Uni-Directiona...
  • 모델명 / 제조번호(시리얼번호)
    Thermocool SmartTouch Bi-Directional Navigation Catheter and Thermocool SmartTouch Uni-Directional Navigation Catheter (used to facilitate electrophysiological mapping of the heart and to undertake RF ablations)Product Code D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All lots manufactured prior to August 30, 2013ARTG Numbers: 184035 & 198574
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd