Events

Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneurysms) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker South Pacific 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-2016-RN-00298-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00298-1
  • 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
    Stryker neurovascular has become aware that the product labels (pouch and carton) for the neuroform atlas stent catheter contains an incorrect conversion from inches to millimetres for the minimum catheter diameter dimension (0.0165in 0.69 mm). the correct dimensions are 0.0165in (0.42mm). this labelling discrepancy could lead to a physician selecting a catheter which is too large. the hazard associated with this is that the stent would prematurely deploy during transfer into the catheter. if this happens, additional procedure/treatment would be required and the patient may be exposed to increased time under anaesthesia.
  • 조치
    The sponsor is advising that the affected devices can continue to be used, provided that the correct dimensions listed in the product directions for use (DFU) are followed. This action has been closed-out on 23/01/2017.

Device

Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneury...
  • 모델명 / 제조번호(시리얼번호)
    Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneurysms)Item numbers: EZAS3024, EZAS3015, EZAS4015, EZAS4530, EZAS3021, EZAS4521 and EZAS4024.All lot numbersSupplied under the Special Access Scheme
  • Manufacturer
    Stryker South Pacific

Manufacturer

Stryker South Pacific
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA