Events

Device Recall PT Graphix Magnet JTIP Guidewire with ICE Hydrophilic Coating 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
    73719
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1370-2016
  • 사례 시작날짜
    2016-03-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-11-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144806
  • 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
    Wire, guide, catheter - Product Code DQX
  • 원인
    Boston scientific is voluntarily implementing a medical device recall of one batch of pt graphix magnet j-tip guidewires. boston scientific has found that, while the batch is labeled as a j-tip model, the guidewires are straight and do not have the pre-formed j-tip. the most severe injury expected to occur is a limited procedure delay caused by the need to replace the guidewire with one that has.
  • 조치
    Boston Scientific sent an "Urgent Medical Device Recall" letter dated March 28, 2016. The letter was addressed to Cath Lab Materials Manager / Field Action Contact. The letter described the problem and the product affected by the recall. Advised consignees to cease immediately further distribution or use of the product and to notify their customers. They also requested consignees to complete and return "The Reply Verification Tracking Form" For questions contact your local Boston scientific sales Representative of the Boston Scientific Filed Action Center..

Device

Device Recall PT Graphix Magnet JTIP Guidewire with ICE Hydrophilic Coating
  • 모델명 / 제조번호(시리얼번호)
    Lot: 17971870
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US nationwide in the states of ME, LA, and TN
  • 제품 설명
    Boston Scientific, PT Graphix Magnet J-TIP Guidewire || with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN referenced on the Pouch Label) . || Boston Scientific PT Graphix Magnet Guidewire with ICE Hydrophilic Coating is a steerable guidewire available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm. PT Graphix Magnet is available with a shapeable Straight Tip or a preformed "J"¿ Tip. || The PT Graphix Magnet Guidewire features a 10 or 38 cm polymer sleeve, coated with ICE Hydrophilic Coating, jacketing the distal tapered core wire. The proximal section of the PT Graphix Magnet Guidewire is coated with a fluorinated polymer.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 2 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