Events

Device Recall Boston Scientific ACUITY Pro Coronary Sinus Guide 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
    72739
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0588-2016
  • 사례 시작날짜
    2015-11-25
  • 사례 출판 날짜
    2016-01-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142058
  • 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 separation of the proximal handle from the shaft.
  • 조치
    Boston Scientific personnel began retrieving product from hospital shelves on November 25, 2015. The hospital was given a Medical Device Retrieval letter. The letter provided the reason for product retrieval, identified affected product, asked for product to be segregated to ensure that it will not be used, and to contact Boston Scientific for a return authorization number to ship product back to Boston Scientific. A Certificate of Removal was asked to be completed and emailed to BSCFieldActionCenter@bsci.com Questions can be addressed to Technical Services at 1-800-227-3422.

Device

Device Recall Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter
  • 모델명 / 제조번호(시리얼번호)
    Model 8104, Lots: 18279548, 18279734, 18324877, 18329863, 18330946, 18348755, 18351569, 18353214, 18426640, 18461104, 18461521.   Model 8105, Lots: 18281110, 18315176, 18322343, 18323156, 18323651, 18324468, 18327210, 18327359, 18345738, 18346540, 18346668, 18347522, 18352159, 18354329, 18379847, 18380498, 18393785, 18394034, 18395315, 18408497, 18408902, 18410018, 18428314, 18435809, 18437015, 18437680, 18439474, 18440388, 18444811, 18445630, 18446236, 18462103, 18462459, 18463154, 18466449, 18478544.   Model 8106, Lots: 18286550, 18410783.   Model 8107, Lots: 18285401, 18285605, 18312411, 18312981, 18313754, 18337534, 18338037, 18354248, 18411116, 18413022, 18413155, 18413834.   Model 8108, Lots: 18273724, 18284294, 18338159, 18414856.   Model 8109, Lots: 18285220, 18293137, 18294062, 18313856, 18314250, 18332118, 18337848, 18353117, 18415202, 18415923, 18416945, 18418278, 18419899.   Model 8110, Lots: 18421013, 18473202.    Model 8111, Lots: 18285930, 18351033, 18353540, 18420652, 18468909 .   Model 8112, Lots: 18291473, 18336768, 18355225, 18421690, 18427953.   Model 8113, Lots: 18324876, 18324963, 18332278, 18352696, 18358192, 18371973, 18372577, 18440783, 18441697, 18467134, 18468171, 18471598, 18472178, 18478892, 18479477.   Model 8114, Lots: 18282143, 18284604, 18335173, 18345117, 18441212, 18442550, 18442887.   Model 8115, Lots: 18288704, 18328790, 18329233, 18356691, 18357371, 18357372, 18372837, 18373201, 18377504, 18378867, 18446665, 18447045, 18451382, 18451950, 18452785, 18453099, 18464410, 18473932, 18477470, 18483223, 18483940.   Model 8116, Lots: 18281865, 18473055.   Model 8117, Lots: 18333920, 18334332, 18466601.   Model 8118, Lots: 18316161, 18336837, 18348081.   Model 8119, Lots: 18286265, 18291252, 18332911, 18336838, 18347898, 18480844, 18483020, 18471580.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, and Thailand.
  • 제품 설명
    Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. || The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature. The catheter shafts are comprised of a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jacket. The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast injection and aspiration polymer .
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • 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