九例不良事件！波士顿科学血管造影导管面临一级召回！

admin · 发表于 2020-10-14 12:32:18

                  <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p> </p><p><span>日前，美国FDA官网发布了一则严重的医疗器械召回通告，召回对象为波士顿科学公司的IMAGER II 5F血管造影导管，该器械是用于在造影手术中为将造影剂送到血管系统的指定部位提供通道。</span></p><p><span> </span></p><p><span>召回通告中显示，由于在患者手术过程或手术准备过程中，血管造影导管的尖端可能会脱落，导致增加额外手术的干预，以去除患者血管中的导管尖端。这不仅会增加患者住院院时间和费用，也可能发生严重不良事件，包括阻塞血流（栓塞），中风或死亡等，目前已收到九例相关不良病例事件，FDA以将此次召回定义为最严重级别的一级召回。</span></p><p><span> </span></p><p><span>波士顿科学在2020年2月11日向客户发送了一封信，通知他们受影响的批号，并提供以下说明：</span></p><p><br  /></p><p><span>删除医院库存中所有受影响的批次；</span></p><p><span>停止使用具有受影响批号的任何产品；</span></p><p><span>填写验证表，并包括每个受影响批次的单位数量；</span></p><p><span>将受影响的批次退还给波士顿科学公司；</span></p><p> </p><p><p><img src="image/20201014/c29e001774ec040fd94362b479d38b70_2.png" /></p></p><p><br  /></p><p><span>此次召回涉及到在美销售的6130个导管（1226包）。</span></p><p><br  /></p><p><span>而事实上，波士顿公司生产的IMAGER II血管造影导管是面向全球销售的，包括美国全国，澳大利亚，比利时，巴西，加拿大，瑞士，中国，哥伦比亚，塞浦路斯，捷克共和国，德国，西班牙，芬兰，法国，英国，希腊，克罗地亚，匈牙利，印度尼西亚，以色列，印度，意大利，约旦，日本，韩国，黎巴嫩，立陶宛，墨西哥，马来西亚，荷兰，挪威，波兰，俄罗斯，瑞典，斯洛伐克，土耳其，台湾和南非。</span></p><p><span> </span></p><p><span> </span></p><p><p><img src="image/20201014/9fac13790086ee284a399d16fa821c74_3.png" /></p></p><p><span> </span></p><p><span>在国家药品监督管理局官网查询到，目前波士顿科学公司在我国有注册一款功能类似的血管造影导管：</span></p><p> </p><p><p><img src="image/20201014/2eee7c6d529d09585dd2151393bff22a_4.png" /></p></p><p> </p><p><span>尚不知道波士顿科学公司是否在中国有销售召回通告中涉及的血管造影导管，截止发稿前，国内尚未查到波士顿科学公司针对以上相关产品的召回信息。</span></p><p><br  /></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br  /></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_5.gif" /></p></section><section data-brushtype="text">戳一下，更有料！</section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  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