Events

Pipeline Embolization Device (PED) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Micro Therapeutics Inc, Dba Ev3 Neurovascular 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
    67893
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1453-2014
  • 사례 시작날짜
    2014-04-01
  • 사례 출판 날짜
    2014-04-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126573
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Catheter, percutaneous - Product Code DQY
  • 원인
    Potential for the ptfe (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
  • 조치
    A customer notification letter was sent on 4/1/14 to all customers who purchased the Pipeline Embolization Device and the Alligator Retrieval Device. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer response form and fax the completed form to Covidien at (763) 591-3519. Customers with questions are instructed to contact Dr. Mark A. Turco at (202) 310-5120. A press release was sent on 4/11/14 to Business Wire Newsroom to inform the public about the recall from Covidien. The recall is regarding certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate adn detach from the devices. Consumers are instructed to report any adverse reactions or quality problems experienced with the use of the product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Consumers with may also contact Covidien Customer Service at (800) 716-6700 between 7am to 7pm (central) or email at customerserviceus@covidien.com.

Device

Pipeline Embolization Device (PED)
  • 모델명 / 제조번호(시리얼번호)
    PED Model/ Lot  FA7735014 / 9879718  FA7742512 / 9864827 FA7150035 / 9855921 FA7735016 / 9856429  FA7742518 / 9856431 FA7730010 / 9869991  FA7737514 / 9855933  FA7742518 / 9860762 FA7732514 / 9873854  FA7737516 / 9858010  FA7745014 / 9874111 FA7735014 / 9855265  FA7740016 / 9859214  FA7745016 / 9879736 FA7735014 / 9875267  FA7740016 / 9879180  FA7747514 / 9868888
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.
  • 제품 설명
    Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
  • Manufacturer
    Micro Therapeutics Inc, Dba Ev3 Neurovascular

Manufacturer

Micro Therapeutics Inc, Dba Ev3 Neurovascular
  • 제조사 주소
    Micro Therapeutics Inc, Dba Ev3 Neurovascular, 9775 Toledo Way, Irvine CA 92618-1811
  • 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
    USFDA