Events

Device Recall iCross Coronary Imaging Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific Corporation 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
    58405
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2419-2011
  • 사례 시작날짜
    2011-03-28
  • 사례 출판 날짜
    2011-06-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99277
  • 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, intravascular, diagnostic - Product Code DQO
  • 원인
    Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. expanded: boston scientific is initiating a recall of all icross coronary imaging catheters because they have received and confirmed 8 occurrences of catheter tip detachments due to embrittlement.
  • 조치
    Boston Scientific " Important Customer Notification" letters dated March 14, 2011 were hand delivered to customers by Boston Scientific sales representatives starting on March 28th, 2011. The sales representatives verbally reviewed information. A tracking log will be maintained document completion of the customer notifications. The letter described the product, problem and possible root cause as well as one corrective action, a change in sterilization method from Gamma to E-beam implementation. Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter dated May 26, 2011, to all affected customers. Customers were instructed to Identify and discontinue use of any affected product within their inventory and to segregate it immediately and return it to Boston Scientific

Device

Device Recall iCross Coronary Imaging Catheter
  • 모델명 / 제조번호(시리얼번호)
    All lots are impacted
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Japan, Trinidad, Tobago, and American Virgin Islands.
  • 제품 설명
    Boston Scientific, Atlantis ¿ SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, USE BY 2011-05, REF 39014, UPN H749390140, Sterile R Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538 || The intended use as stated in Japan Shonin 21200BZY00484000: This product is an imaging catheter with built-in ultrasonic transducer that sends ultrasound waves inside the blood vessel to perform B-mode ultrasonagraphy. The indications for use as stated in the 510(k) and DFU 90606867: The Atlantis coronary catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular Ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • 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