Events

Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of 200 mm only) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Biotronik Australia 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-2015-RN-00440-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-05-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00440-1
  • 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
    Biotronik has received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of our pulsar-18 and pulsar-35 peripheral self-expanding nitinol stent systems. potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury or the need to remove the incompletely deployed stent. stents that have already been implanted are not affected as the issue occurs during deployment of the stent.
  • 조치
    Users are advised to discontinue any further use of the affected stock and remove them from their inventory. A sales representative will contact customers to collect the affected stock. This action has been closed-out on 02/12/2016.

Device

Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of...
  • 모델명 / 제조번호(시리얼번호)
    Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of 200 mm only) Pulsar-35Product Codes: 379921, 379941, 379926, 379946, 379931, 379951Specific LotsARTG number: 169368 Pulsar-18 Product Codes: 366812, 366832, 366817, 366837, 366822, 366842, 366827, 366847Specific LotsARTG number: 142025
  • Manufacturer
    Biotronik Australia Pty Ltd

Manufacturer

Biotronik Australia Pty Ltd
  • 제조사 모회사 (2017)
    Ms Holding Ii Se
  • 제조사 의견
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    DHTGA