Events

ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a left ventricular pacing lead) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Boston Scientific 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-01192-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01192-1
  • 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
    Boston scientific is recalling certain lots of 9fr acuity pro coronary sinus outer guide catheters due to potential for separation of the proximal handle from the shaft. boston scientific's investigation concluded that if the hub and shaft are aligned off-centre in the bonding equipment during manufacturing, the result may be a reduced bond, which may separate during cutting. the affected products were manufactured during the time period when the equipment was likely to be misaligned.The most serious injury foreseeable with unexpected hub detachment is a moderate delay in the procedure to reposition a dislodged lead. boston scientific has received reports of handle separations during the cut and removal process; there have been no reports of patient harm.
  • 조치
    Customers are advised to immediately segregate all affected products to ensure that it will not be used and to ship the stock back to Boston Scientific for replacement with unaffected stock. This action has been closed-out on 24/08/2016.

Device

ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a...
  • 모델명 / 제조번호(시리얼번호)
    ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a left ventricular pacing lead)Model Numbers: 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, 8119Multiple Lot Numbers affectedARTG Number: 222220
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA