Transcript ETM627F14 Grose vascular snare Recall

Product Recall
 What: Cook CloverSnare 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]
ETM627—Emma Grose—Vascular Retrieval Snare—Sunday, November 30
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The Snare
 Purpose: “The CloverSnare 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/CloverSnare_4Loop
_Vascular_Retrieval_Snare_Recall/
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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 detailing Cook
Medical’s response to the recall was outlined; however, the initial letter sent to all
customers did state that a credit would be given to all companies who purchased the
device. Articles were not found detailing the four incidents leading to the recall. [2]
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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.
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References
[1] "AboutLawsuits.com." AboutLawsuitscom. N.p., n.d.Web. 28 Nov. 2014.
[2] "Class I Medical Device Recall: Cook CloverSnare 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 CloverSnare 4LoopVascular Retrieval Snare. N.p., n.d.Web. 28 Nov. 2014.
[4] "CloverSnare™ 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 CloverSnare 4-LoopVascular Retrieval
Snare. N.p., n.d.Web. 28 Nov. 2014.
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