Events

Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set (used to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract) 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-2013-RN-01141-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01141-1
  • 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 has received reports from the field that the tip of the dilator has separated from the body of the dilator during procedure. if the tip broke off as the shaft was being advanced near the ureteopelvic junction (upj), then inadvertent blunt trauma to the renal parenchyma or renal hilar vessels could occur. this could produce anything from a small haematoma up to haemorrhage requiring medical therapy (transfusion), radiologic intervention (embolisation) or surgery (nephrectomy). however, in most cases the attempted removal of the tip would result in a second intervention. unless the tip fell off in the packaging or at placement over the guidewire the defect is unlikely to be detected prior to the procedure.
  • 조치
    Boston Scientific are requesting users to inspect current stock and quarantine affected batches. Affected product can be returned to Boston Scientific for replacement or a credit note.

Device

Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set (used to facilitate the passage...
  • 모델명 / 제조번호(시리얼번호)
    Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set (used to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract)Catalogue Numbers: 250-227, 250-228 and 250-229 Material Numbers: M0062502270, M0062502280 and M0062502290Multiple Lot Numbers affectedARTG Number: 126446
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 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