本文摘譯自FDA 2020年5月12日

以下為詳文

FDA已認(rèn)定這是一級(jí)召回，此為最嚴(yán)重的召回類型。因?yàn)槭褂眠@些設(shè)備可能會(huì)導(dǎo)致嚴(yán)重傷害或死亡。

召回產(chǎn)品：

? ? Python取栓導(dǎo)管、Bard取栓導(dǎo)管和OTW Latis清洗導(dǎo)管

產(chǎn)品型號(hào)：

? ??Python取栓導(dǎo)管：A4E01，A4E02，A4E03，A4E04，A4E05，A4E06，A4E08，A4E09；

? ?Bard取栓導(dǎo)管：CE0340DR，CE0380DR，CE0440DR，CE0480DR CE0540DR，CE0580DR，CE0680DR；

? ?? ?OTW Latis清洗導(dǎo)管：A4GW6

制造日期：2015年7月23日至2018年11月8日

發(fā)行日期：2015年8月25日至2019年3月1日

在美國(guó)召回的設(shè)備有：19,400

公司發(fā)起召回日期：2019年10月24日

設(shè)備用途

Python取栓導(dǎo)管、Bard取栓導(dǎo)管和OTW Latis清洗導(dǎo)管是乳膠球囊導(dǎo)管，用于暫時(shí)阻塞、關(guān)閉血管或輸液。?

召回原因

因?yàn)镻ython取栓導(dǎo)管、Bard取栓導(dǎo)管和OTW Latis清洗導(dǎo)管在使用過(guò)程中，存在導(dǎo)管尖端部件脫落的風(fēng)險(xiǎn)，如果導(dǎo)管尖端部件脫落，其零件有可能斷開，從而進(jìn)入到患者的體內(nèi)。

這種情況一旦發(fā)生，同樣會(huì)造成嚴(yán)重健康后果，其中包括移除尖端部件的額外手術(shù)、血管損傷或?qū)е滤劳觥?/span>

自2015年以來(lái)，已經(jīng)有46起關(guān)于該設(shè)備問(wèn)題的投訴。FDA已收到了三份醫(yī)療器械報(bào)告（MDRs），但無(wú)死亡或受傷的報(bào)告。?

誰(shuí)可能會(huì)受到影響

? ? 使用受影響的Python取栓導(dǎo)管、Bard取栓導(dǎo)管和OTW Latis清洗導(dǎo)管的醫(yī)療服務(wù)提供者

? ? 用受影響的導(dǎo)管實(shí)施手術(shù)的患者

該怎么辦

2019年11月8日，Applied Medical公司發(fā)出一份緊急通知——給所有受影響的客戶發(fā)出《醫(yī)療器械召回函》，說(shuō)明如下：

? ? 1、請(qǐng)檢查被召回產(chǎn)品的庫(kù)存。

? ? 2、填寫《召回通知確認(rèn)表》，確認(rèn)召回，并說(shuō)明您的設(shè)備是否正在退回中或已經(jīng)使用了上述批次的產(chǎn)品。

? ? 3、如果沒(méi)有退回任何產(chǎn)品，請(qǐng)?jiān)凇墩倩赝ㄖ_認(rèn)表》上注明。

? ? 4、如果您是經(jīng)銷商，請(qǐng)通知接收到本次召回受影響產(chǎn)品的所有醫(yī)療機(jī)構(gòu)，請(qǐng)同時(shí)填寫《召回通知確認(rèn)表》的第4頁(yè)。

? ?5、將《召回通知確認(rèn)表》以電子郵件發(fā)送至Applied Medical 10310330@appliedmedical.com或傳真至949-713-8908。

? ? 6、把受影響產(chǎn)品和《召回通知確認(rèn)表》的副本退還給Applied Medical公司，（產(chǎn)品退貨說(shuō)明見第5頁(yè)）。

聯(lián)系方式

有關(guān)產(chǎn)品退貨的聯(lián)系方式：

電話：949-713-8688，或E-mail：jrios@appliedmedical.com，

聯(lián)系人：客戶關(guān)系部高級(jí)經(jīng)理Jaclene Rios-Simpson。

有關(guān)法規(guī)的聯(lián)系方式：

電話：949-713-8767，或E-mail：lcontursi@appliedmedical.com，

聯(lián)系人：Lauren Contursi。

其他：

? ? Python取栓術(shù)召回?cái)?shù)據(jù)庫(kù)登錄

? ? BARD取栓術(shù)召回?cái)?shù)據(jù)庫(kù)登錄

? ? OTW Latis清洗導(dǎo)管召回?cái)?shù)據(jù)庫(kù)登錄

如何報(bào)告？

專業(yè)醫(yī)務(wù)人員和消費(fèi)者可以報(bào)告他們?cè)谑褂眠@些設(shè)備時(shí)遇到的不良反應(yīng)或質(zhì)量問(wèn)題。請(qǐng)使用FDA安全性信息和不良事件報(bào)告系統(tǒng)（即MedWatch系統(tǒng)）的在線表格、常規(guī)郵件或傳真等方式進(jìn)行報(bào)告。

原文：

Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

Python Embolectomy Catheters, Bard Embolectomy Catheters, and the OTW Latis Cleaning Catheters

Model Numbers:

Python Embolectomy Catheters: A4E01, A4E02, A4E03, A4E04, A4E05, A4E06, A4E08, A4E09

Bard Embolectomy Catheters: CE0340DR, CE0380DR , CE0440DR,CE0480DR CE0540DR, CE0580DR, CE0680DR

OTW Latis Cleaning Catheters: A4GW6

Manufacturing Dates: July 23, 2015 to November 8, 2018

Distribution Dates: August 25, 2015 to March 1, 2019

Devices Recalled in the U.S.: 19,400

Date Initiated by Firm: October 24, 2019

Device Use

The Python Embolectomy Catheters, Bard Embolectomy Catheters, and OTW Latis Cleaning Catheters are latex balloon catheters used for temporary blockage, closing of a blood vessel, or infusion of fluids.?

Reason for Recall

Applied Medical is recalling their Python Embolectomy Catheters, Bard Embolectomy Catheters, and OTW Latis Cleaning Catheters because there is a risk of the catheter tip detaching during use. If the tip detaches, pieces of the catheter could break off into the patient’s body.

If this occurs, there is also the potential for serious health consequences including additional surgical procedures to remove the tip, damage to the blood vessel, or death.

There have been 46 complaints regarding this device issue since 2015. The FDA has received three medical device reports (MDRs) and no reports of death or injury.?

Who May be Affected

Health care providers using affected Python Embolectomy, Bard Embolectomy, and the OTW Latis Cleaning Catheters

Patients undergoing procedures using affected catheters

What to Do

On November 08, 2019, Applied Medical sent an Urgent: Medical Device Recall Letter to all affected customers with the following instructions:

Check your inventory for the recalled product.

Complete the Recall Notification Confirmation Form to acknowledge the recall and indicate if your facility is returning or has already used product from the lot listed above.

If no product is being returned, please indicate on the Recall Notification Confirmation Form.

If you are a distributor, please notify all the facilities that received the affected product of this recall. Please also complete Page 4 of the Recall Notification Confirmation Form.

Return the Recall Notification Confirmation Form to Applied Medical by email to recall60810330@appliedmedical.com or by fax to 949-713-8908.

Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical (Product Return Instructions are on Page 5).

Contact Information

For product return questions, please contact Jaclene Rios-Simpson, Senior Manager, Customer Relations at 949-713-8688 or jrios@appliedmedical.com. For regulatory questions, please contact Lauren Contursi, at 949-713-8767 or lcontursi@appliedmedical.com.

Additional Resources:

Python Embolectomy Recall Database Entry

BARD Embolectomy Recall Database Entry

OTW Latis Cleaning Catheters Recall Database Entry

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.