In some instances, physicians and nurses in Nashville feel that it is appropriate to alter a medical device to meet the needs of an individual patient. Sometimes, however, products may not be suitable for these types of changes due to a design or manufacturing defect. When this occurs, the resulting injuries may require medical intervention to correct.
Six reports have been made regarding CloverSnare 4-Loop Vascular Retrieval Snare medical devices, resulting in a recall. These products were discovered to have a defect that allows the loop snare to separate from the shaft if attempts are made to change the device's shape. It is unclear from reports whether the manipulation of the product's shape is part of its intended use.
When the shaft and loop separate, there is a risk for snare fragment embolization. Medical intervention may be required to properly retrieve the snare; this was the case in four of the six reported incidents.
Approximately 700 units are affected by this recall. Consumers are being asked to return these devices to the company, Cook Medical. It is unclear from reports whether consumers will receive replacements, reimbursements or some other form of compensation when they return their defective products.
When someone experiences an injury due to a malfunctioning device, recovery can be very time-consuming and expensive. To address related financial and psychological damages, some consumers who have suffered negative health implications from defective medical devices choose to file civil suits against the products' manufacturers. Those who have suffered an injury due to a defective medical product and wish to learn more about this option may want to consult with an attorney.
Source: FDA.gov, "CloverSnare 4-Loop Vascular Retrieval Snare Recall," Aug. 19, 2014