Events

Copernic2L and Eclipse2L Occlusion Balloon Catheters 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Getz Healthcare 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-2017-RN-01311-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01311-1
  • 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
    Getz healthcare is advising that damages on the catheters' tubes have been observed during post-marketing surveillance program. this may lead to unusual balloon behaviour during the contrast liquid injection through the guiding catheter, such as unexpected inflation and/or difficult deflation.The manufacturer, balt extrusion has received 3 reports of cases involving this issue, but there have been no reports of patient injury due to these types of failures on the devices. however, these kinds of incidents may lead to patient injury with vascular trauma if the devices are not used in accordance with the recommendations.
  • 조치
    Getz Healthcare is advising users to not insert the double lumen catheters ECLIPSE2L and COPERNIC2L through the Y­ connector's side-arm; they shall be inserted through the axial-arm to prevent any deterioration of the tube. The Instructions for Use will be updated as a permanent measure.

Device

Copernic2L and Eclipse2L Occlusion Balloon Catheters
  • 모델명 / 제조번호(시리얼번호)
    Copernic2L and Eclipse2L Occlusion Balloon CathetersAll Lot NumbersARTG Numbers: 263592 (Getz Healthcare Pty Ltd - COPERNIC 2L occlusion balloon catheter - Catheter, intravascular, occluding) and;263593 (Getz Healthcare Pty Ltd - ECLIPSE 2L occlusion balloon catheter - Catheter, intravascular, occluding)
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd