Events

PENTARAY® NAV Catheters, PENTARAY® NAV eco Catheters 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Biosense Webster 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2017-05-05
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    At biosense webster, we are committed to ensuring patient safety, so we are constantly monitoring the performance of our products to meet our customers' expectations. biosense webster would like to further clarify the record of contraindications in the package leaflet and on the product labels of this catheter regarding patients with prosthetic flaps. an existing record in the instructions for use warns against using the pentaray® catheter on prosthetic flap patients, which states in the contraindication paragraph: “this catheter may not be suitable for use on prosthetic flap patients.” the package leaflet has been updated for additional clarification a contraindication record that now reads: "do not use pentaray® catheters on patients with prosthetic flaps".

Device

PENTARAY® NAV Catheters, PENTARAY® NAV eco Catheters

Manufacturer

Biosense Webster