Product Recall What Cook Clover Snare 4 Loop

Product Recall What: Cook Clover. Snare 4 -Loop Vascular Retrieval Snare Recall Date: July 17, 2014 [1] Why: The snare tip may break during use and separate from the shaft. If this occurs, this loop could travel through the vascular system, thus causing blood vessels to be blocked. The detached snare could also travel to organs in the body and get stuck. [3] Incidents: At least four reports of injuries [2] Number of Units Sold: In the United States (the only country this device was sold), 671 devices had been distributed. [1] When Sold: Manufactured from August 2012 to August 2013 and Sold from March 8, 2013 until July 1, 2014 [1] ETM 627—Emma Grose—Vascular Retrieval Snare—Sunday, November 30 1

The Snare Purpose: “The Clover. Snare 4 -Loop Vascular Retrieval Snare is used to manipulate and retrieve items in the cardiovascular system, such as temporary implanted devices. ” [5] Examples: Broken implanted devices, vena cava filters, guide wires, coils, balloons, catheters [5] http: //www. magmutual. com/recall-issued-cookcloversnare-4 -loop-vascular-retrieval-snare http: //article. wn. com/view/2014/08/19/Clover. Snare_4 Loop _Vascular_Retrieval_Snare_Recall/ ETM 627—Emma Grose—Vascular Retrieval Snare—Sunday, November 30 2

Management Issues Recognition of Problem: The Retrieval Snare had not been on the market for a long period of time. When the device was recalled on July 17, 2014, only 671 devices had been distributed. On this date, Cook Medical sent all customers an “Urgent Medical Device Recall letter informing them of the product, problem, and actions to be taken. ” The letter advised customers to collect and return any unused products and mail them back to Cook Medical as soon as possible. Credit would be given. Cook Medical also urged customers to fill out the Recalled Product Reply Form. [1] Speed of Response: A class I recall was issued. A press released was issued on August 26, which is no longer able to be found. A class I recall is the most serious recall. When a class I recall is issued, there is reason to believe that using the recalled product may cause serious health risks or even death. No information was found on how many of the sold devices were returned; however, the specific item is no longer on the market. [1] Responsibility: No information was found in which information Grose—Vascular Snare—Sunday, November 30 3 detailing ETM 627—Emma Cook Medical’s response to. Retrieval the recall was outlined; however, the initial letter sent to all customers did state that a credit would be

Impact of Recall Legal Consequences: No information could be found regarding the legal consequences of this recall. The press release from August 2014 is no longer available. Reputation: The recall of this one device does not seem to have had a major effect on the reputation of Cook Medical. The company is still hiring many employees, many devices are still being sold, and the reputation of the company does not seem to be affected at all. Sales: This particular vascular retrieval snare was removed from the market; however, not all vascular retrieval snares have been removed. Some are still in use and used by physicians today. ETM 627—Emma Grose—Vascular Retrieval Snare—Sunday, November 30 4

References [1] "About. Lawsuits. com. " About. Lawsuitscom. N. p. , n. d. Web. 28 Nov. 2014. [2] "Class I Medical Device Recall: Cook Clover. Snare 4 -Loop Vascular Retrieval Snare - Snare Tip May Break During Use. " Product News Update. N. p. , n. d. Web. 28 Nov. 2014. [3] "Health Education Community. " Class I Medical Device Recall: Cook Clover. Snare 4 -Loop Vascular Retrieval Snare. N. p. , n. d. Web. 28 Nov. 2014. [4] "Clover. Snare™ 4 -Loop Vascular Retrieval Snare Recall. " World News. N. p. , n. d. Web. 28 Nov. 2014. [5] "Medical Healthcare News. " Medical Healthcare News. N. p. , n. d. Web. 28 Nov. 2014. [6] "U. S. Food and Drug Administration. " Cook Clover. Snare 4 -Loop Vascular. ETM 627—Emma Retrieval Snare. N. p. , n. d. Web. 28 Nov. 2014. Grose—Vascular Retrieval Snare—Sunday, November 30 5