Events

Device Recall IntelliTip MiFi XP Asymmetric Curve Temperature Ablation Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific Corp 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
    72721
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0465-2016
  • 사례 시작날짜
    2015-11-20
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142033
  • 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, cardiac ablation, for treatment of atrial flutter - Product Code OAD
  • 원인
    During routine monitoring of complaints, bsc noted that the intellatip mifi xp n4 complaint rate for distal tip bends/kinks was above the anticipated rate in bsc's product risk documentation.
  • 조치
    Boston Scientific sent an Urgent Medical Device Removal letters to all affected customers dated November 20, 2015 via Fed Ex or other equivalent service. The letter identified the affected products, problem and actions to be taken. Customers were instructed to contact their local Sales Representative to answer any questions.

Device

Device Recall IntelliTip MiFi XP Asymmetric Curve Temperature Ablation Catheter
  • 모델명 / 제조번호(시리얼번호)
    Material Number: M004PM4790N40;  Catalog number: PM4790N4; Lot numbers: 16743269, 16818653, 16818654, 16872007, 16993525, 17511087, 18159904, 18385792. Expiration Date Range: 9/1/2016 to 9/20/2018. .
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the state of: PA, FL, IN, MI, TN, AL, IL, KY, MI, TX, OH, MO, MA, MN, ID, AL, TN, VA, CA and internationally to Austria, Australia, Belgium, Switzerland, Germany, Great Britain, Greece, Hong Kong, Israel, Iran, Italy, Japan, Kuwait, Latvia, Malaysia, Netherlands, Saudi Arabia, Singapore, Thailand, and South Africa.
  • 제품 설명
    IntellaTip MiFi XP Asymmetric (N4) Curve || 7/110/2.5/8-10 ; || Material Number: M004PM4790N40; Catalog number: PM4790N4; || Cardiac: || The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia  typically chronic, drug refractory atrial fibrillation.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • 제조사 주소
    Boston Scientific Corp, 150 Baytech Dr, San Jose CA 95134-2302
  • 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
    USFDA