Events

WATCHMAN FLX™ Left Atrial Appendage (LAA) Closure Device 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 Boston Scientific International S.A. 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
  • 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
    Boston scientific is implementing a voluntary medical device removal of all non-implanted watchman flx™ left atrial appendage closure (laac) devices. the reason for this action is that boston scientific has received an increased number (6 of 207 – 2.9%) of implant embolization reports both during procedure (2) and post procedure (4) on the watchman flx laac devices. each embolized flx device was successfully retrieved percutaneously without permanent embolization. note: one patient died due to complications related to a post-operative infection after percutaneous removal of their flx device. .

Device

WATCHMAN FLX™ Left Atrial Appendage (LAA) Closure Device
  • 모델명 / 제조번호(시리얼번호)
    WS5020 18225672, 18225673, 18225674, 18396812, 18401612, 18459184, 18581834, 18603231, 18682283, 18688431, 18688432, 18707084, 18736313, 18751534, 18751536, 18838165, 18845130, 18875658, 18900177, 18914801, 18914802, 18929298 WS5024 18396813, 18401613, 18408201, 18408202, 18435076, 18480472, 18492730, 18581835, 18591486, 18603232, 18682284, 18682288, 18688428, 18707085, 18736314, 18742868, 18751537, 18838166, 18866426, 18900176, 18914803, 18915361, 18934783, 18944586, 18972521, 18979870 WS5027 18396814, 18408203, 18409435, 18435077, 18459185, 18492731, 18581836, 18591490, 18682285, 18682289, 18707086, 18736315, 18751538, 18751539, 18838167, 18866427, 18876065, 18908883, 18914808, 18914809, 18914810, 18914811, 18914812, 18929299, 18934786, 18944584, 18944587, 18972522, 18979879, 18989184 WS5031 18396811, 18408205, 18435078, 18459186, 18534734, 18581837, 18591358, 18682286, 18707087, 18736316, 18752110, 18832856, 18845134, 18876063, 18893436, 18914813, 18934784, 18944588, 18980043, 18989186 WS5035 18182797, 18225668, 18225671, 18401059, 18435079, 18483583, 18581838, 18682287, 18707088, 18736317, 18751760, 18832857, 18845135, 18876066, 18900178, 18914814, 18934785
  • Manufacturer
    Boston Scientific International S.A.

Manufacturer

Boston Scientific International S.A.
  • 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
    AMPMDRS