食品药品管理局发早期警报：Arrow导丝亲水涂层可能脱落入血 相关导管产品被要求撤下停用
华盛顿—美国食品药品管理局（FDA）11月10日发布早期警报，通报一个可能属高风险的医疗器械问题：Teleflex 子公司 Arrow International 已致函受影响客户，建议撤下含有弹簧导丝（Spring Wire Guide）组件的相关产品。FDA 表示正审查这一问题，并将随新信息更新通报。
受影响产品包括 Arrow 标记亲水涂层镍钛导丝与不锈钢导丝，以及多款含这类导丝的可加压注射导管，包括 Arrowg+ard Blue Advance 系列的单腔、双腔与三腔 PICC 导管及相关套件。Arrow 导丝用于协助把导管置入血管，相关导管用于输注药物与液体、采集血样。
FDA 说，Arrow International 表示，所供亲水涂层弹簧导丝组件存在潜在质量问题：涂层遇生理盐水水合时可能不均匀溶胀、结块并脱落。脱落的涂层微粒可进入血流、增加栓塞风险，亲水聚合物栓塞可能引发炎症、血栓、缺血、组织损伤、中风、追加干预甚至死亡。
Arrow International 已于11月5日致函全部受影响客户，要求立即清查库存、停止使用与分销并隔离相关产品，联系 Teleflex 客户服务退回产品，并把召回通知副本提供给所有收到受影响产品的客户。截至11月5日，该公司报告尚无与此问题相关的重伤或死亡。
在美客户如遇不良反应、质量问题或有疑问，可联系 Arrow International（[email protected] 或 1-866-396-2111）；医护人员与消费者也可通过 FDA 的 MedWatch 计划报告不良反应或质量问题。
（来源：美国食品药品管理局）
FDA Issues Early Alert: Arrow Guidewire Coating May Detach Into the Bloodstream, Catheter Products Removed
WASHINGTON — The U.S. Food and Drug Administration (FDA) issued an Early Alert on November 10 about a potentially high-risk medical device issue: Arrow International, a subsidiary of Teleflex Incorporated, has sent a letter to affected customers recommending that certain products containing Spring Wire Guide components be removed from where they are used or sold. The FDA said it is reviewing the issue and will update the public as significant new information becomes available.
Affected products include the Arrow Marked Guidewire in hydrophilic-coated nitinol and stainless steel versions, and a range of pressure-injectable catheters containing those guidewires, including one-, two- and three-lumen PICC products in the Arrowg+ard Blue Advance line and related kits. Arrow coated guidewires help place catheters in blood vessels, and the affected catheters are used to deliver medicines and fluids and to collect blood samples.
According to the FDA, Arrow International stated there is a potential quality issue with the supplied hydrophilic-coated Spring Wire Guide components: Teleflex confirmed the coating may swell inconsistently when hydrated with saline, leading to clumping of the coating and potential detachment. Detachment could release particles into the bloodstream, increasing the risk of emboli, and hydrophilic polymer emboli may have adverse health consequences including inflammation, thrombosis, ischemia, tissue injury, stroke, further intervention, or death.
On November 5, Arrow International sent all affected customers a letter recommending they immediately check inventory, cease use and distribution of affected product and quarantine it, contact Teleflex Customer Service to return it, and provide a copy of the recall notice to all customers who received impacted product. As of November 5, the company had reported no serious injuries or deaths associated with the issue.
Customers in the U.S. with adverse reactions, quality problems, or questions should contact Arrow International at [email protected] or 1-866-396-2111. Health care professionals and consumers may also report problems through the FDA's MedWatch program.
(Source: U.S. Food and Drug Administration)
来源：美国食品药品管理局
发布：GSM·美国（发布链接）
图片来源：图：美国食品药品管理局（FDA）总部大楼入口，楼面有 FOOD AND DRUG ADMINISTRATION 标识。GSM 联邦固定图库。 / Photo: The entrance of the U.S. Food and Drug Administration headquarters, bearing the agency's name. GSM federal asset library.
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