Events

THERMOCOOL SMARTTOUCH BI-DIRECTONAL NAVIGATION CATHETER 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    25953
  • 사례 위험등급
    II
  • 사례 시작날짜
    2014-10-27
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Biosense webster has observed 34 complaints with a frequency of 0.03% related to a bend/crack at different locations of the shaft of the thermocool smarttouch catheter between january 2012 and july 2014. none of these complaints were associated with adverse events. manual pre-shaping of the distal shaft of the catheter and use of 8 fr sheaths were identified as the two primary causes of these events. the purpose of the field safety notice is to reinforce the warnings and precautions and directions for use in the current ifu as well as to notify customers of upcoming updates to the ifu's warnings and precautions.

Device

THERMOCOOL SMARTTOUCH BI-DIRECTONAL NAVIGATION CATHETER
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: D132705 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132704 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132701 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132702 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132703 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D133603 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D133601 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D133602 (Lot serial: >100 NUMBERS CONTACT MFR)
  • 제품 설명
    THERMOCOOL SMARTTOUCH CATHETER (BI-DIR)
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.