Events

Symplicity Catheters 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic Ltd. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2013-01-28
  • 사례 출판 날짜
    2013-01-28
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130128.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medtronic symplicity catheters medical device manufacturer, medtronic ltd., has issued a field safety notice concerning symplicity catheters. the affected model numbers are iderdn006 and rdn006. the manufacturer has observed a connection issue complaint rate of approximately 5% of devices provided since enrollment of the symplicity htn3 trial began. these connection issues cause unstable temperature readings or lack of signal to the generator. in events where a connection failure leads to unstable temperature reading, the generator’s safety algorithm is triggered and energy delivery is terminated, or if there is a lack of signal to the generator, it will not initiate treatment, thus in either situation protecting the patient from unsafe treatment. these connection issues manifest in one of the following ways: a flickering generator display screen upon initial catheter connection generator status display of “check connection” rapid fluctuations in the temperature reading multiple early termination of energy delivery accompanied by “check status” safety codes 22, 23 and/or 32 despite confirming electrode placement as defined by the ifu. the result of these connection failures is the potential need during the procedure to replace the catheter to successfully complete the renal denervation procedure. the manufacturer advises users to connect the catheter into the generator prior to inserting into the patient according to the ifu. furthermore, the manufacturer advises users that if observing any of the conditions above, they should follow the steps below: assure the catheter connector plug is fully seated into the generator by unplugging and re-plugging the catheter. if this resolves the issue, continue with treatment. gently wiggle the connector plug. if this resolves the issue, continue with treatment. if the issue remains, replace the catheter and return the catheter to medtronic for investigation. medtronic has also developed a new catheter connector. according to the local supplier, medtronic international limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 january 2013.

Device

Symplicity Catheters
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Symplicity Catheters
  • Manufacturer
    Medtronic Ltd.

Manufacturer

Medtronic Ltd.
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH