Events

Biosense ThermoCool SF Nav Bi-Directional Catheter 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Biosense Webster Inc 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
    16575
  • 사례 시작날짜
    2014-05-23
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • 원인
    The manufacturer has revised the procedural steps and precautions set out in the ifu, 1. when using the devices with conventional systems (using fluroscopy to determine catheter tip location) or with the carto ep navigations system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade., 2. do not use the temperature sensor to monitor tissue temperature., 3. precautionary measures should be taken when ablating on the posterior wall of the left atrium in proximity to the oesophagus to minimse risk of atrio-esophageal fistula.
  • 조치
    Instructions for use to be updated

Device

Biosense ThermoCool SF Nav Bi-Directional Catheter
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: All lots
  • Manufacturer
    Biosense Webster Inc

Manufacturer

Biosense Webster Inc