Events

Device Recall FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 7.0 mm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Vascular, Inc. 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
    67646
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1305-2014
  • 사례 시작날짜
    2014-03-03
  • 사례 출판 날짜
    2014-03-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125901
  • 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
    Temporary Carotid Catheter for Embolic Capture - Product Code NTE
  • 원인
    Medtronic is recalling a specific subset of lot numbers of the fibernet embolic protection system (eps) where the yellow polyimide tube on the fibernet eps was not removed from the fibernet eps during the manufacturing process and subsequently may remain on the fibernet eps.
  • 조치
    Medtronic sent an Urgent Device Recall letter dated March 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records show that your facility has received one or more of these FIBERNET EPS, as shown in the attachment to this notification. Consequently, Medtronic requests you immediately take the following actions: 1. Immediately remove and quarantine all potentially affected product that remains in your inventory. 2. Return these units to Medtronic. Contact Customer Service at 1-888- 283-7868 and reference RADAR # 174028 to initiate a return and credit of product. A Medtronic representative can assist in facilitating the return and replacement of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and email to RS.CFQFCA@Medtronic.com, or fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. Medtronic has taken the necessary steps to prevent any future shipment of the potentially affected product. Regulatory agencies will be notified about this recall as applicable. Please share this notification with others in your organization as appropriate. lf any FIBERNET EPS within the scope of this recall have been forwarded to another facility, please notify that facility accordingly and facilitate the retrieval of the affected product. We apologize for the inconvenience this may cause you; please be assured that patient safety and product quality remain our primary concern. Should you have any questions, please contact your Medtronic representative or Medtronic LifeLine Technical Services at 1 (877) 526-7890 or (+1 763) 526-7890.

Device

Device Recall FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 7.0 mm
  • 모델명 / 제조번호(시리얼번호)
    US Model Number FBC 600700190, lot number 1E029750; International Model Number: FBN600700190: lot numbers 1E012916, 1E017817.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.
  • 제품 설명
    FIBERNET Embolic Protection System: || Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: || 0.014 in (0.36mm) || Rx only, Sterile; || Manufactured in: || Invatec S.P.A., Italy; || Manufacturer: || Medtronic Inc. || Minneapolis, MN. || The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.
  • Manufacturer
    Medtronic Vascular, Inc.

Manufacturer

Medtronic Vascular, Inc.
  • 제조사 주소
    Medtronic Vascular, Inc., 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • 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