本文摘譯自FDA 2020年5月12日

以下為詳文

FDA已認定這是一級召回，此為最嚴重的召回類型。因為使用這些設備可能會導致嚴重傷害或死亡。

召回產品：

? ? Python取栓導管、Bard取栓導管和OTW Latis清洗導管

產品型號：

? ??Python取栓導管：A4E01，A4E02，A4E03，A4E04，A4E05，A4E06，A4E08，A4E09；

? ?Bard取栓導管：CE0340DR，CE0380DR，CE0440DR，CE0480DR CE0540DR，CE0580DR，CE0680DR；

? ?? ?OTW Latis清洗導管：A4GW6

制造日期：2015年7月23日至2018年11月8日

發行日期：2015年8月25日至2019年3月1日

在美國召回的設備有：19,400

公司發起召回日期：2019年10月24日

設備用途

Python取栓導管、Bard取栓導管和OTW Latis清洗導管是乳膠球囊導管，用于暫時阻塞、關閉血管或輸液。?

召回原因

因為Python取栓導管、Bard取栓導管和OTW Latis清洗導管在使用過程中，存在導管尖端部件脫落的風險，如果導管尖端部件脫落，其零件有可能斷開，從而進入到患者的體內。

這種情況一旦發生，同樣會造成嚴重健康后果，其中包括移除尖端部件的額外手術、血管損傷或導致死亡。

自2015年以來，已經有46起關于該設備問題的投訴。FDA已收到了三份醫療器械報告（MDRs），但無死亡或受傷的報告。?

誰可能會受到影響

? ? 使用受影響的Python取栓導管、Bard取栓導管和OTW Latis清洗導管的醫療服務提供者

? ? 用受影響的導管實施手術的患者

該怎么辦

2019年11月8日，Applied Medical公司發出一份緊急通知——給所有受影響的客戶發出《醫療器械召回函》，說明如下：

? ? 1、請檢查被召回產品的庫存。

? ? 2、填寫《召回通知確認表》，確認召回，并說明您的設備是否正在退回中或已經使用了上述批次的產品。

? ? 3、如果沒有退回任何產品，請在《召回通知確認表》上注明。

? ? 4、如果您是經銷商，請通知接收到本次召回受影響產品的所有醫療機構，請同時填寫《召回通知確認表》的第4頁。

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

? ? 6、把受影響產品和《召回通知確認表》的副本退還給Applied Medical公司，（產品退貨說明見第5頁）。

聯系方式

有關產品退貨的聯系方式：

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

聯系人：客戶關系部高級經理Jaclene Rios-Simpson。

有關法規的聯系方式：

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

聯系人：Lauren Contursi。

其他：

? ? Python取栓術召回數據庫登錄

? ? BARD取栓術召回數據庫登錄

? ? OTW Latis清洗導管召回數據庫登錄

如何報告？

專業醫務人員和消費者可以報告他們在使用這些設備時遇到的不良反應或質量問題。請使用FDA安全性信息和不良事件報告系統（即MedWatch系統）的在線表格、常規郵件或傳真等方式進行報告。

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.