Continuous peripheral nerve block is becoming an increasingly popular method to relieve pain at the site of surgery. The Arrow StimuCath is one catheter device in a line of products designed to use electrical stimulation for aid in localizing nerves and optimizing placement of nerve catheters to reduce pain scores and opioid consumption.
Perineural catheters are often placed on an ambulatory basis and removed by the patient within days of the surgery. This is especially problematic when complications arise and there are issues of proximity to the provider. Prior to surgery, a catheter is placed under the skin in the area containing the nerves that provide feeling to the area where the surgery will be performed.
The catheter is connected to a pump, and a local anesthetic is transfused through the catheter continuously at a pre-determined rate for around 12-18 hours. After an additional 12 hours when the effect of the local anesthetic has worn off and sensation has returned, the catheter may be removed. The FDA has cleared all Arrow Epidural Catheters for use up to 72 hours.
It is during the catheter removal that potentially serious complications arise, and the majority of these complications involve the Arrow StimuCath catheter. Catheters can be difficult to remove due to a condition called nerve entrapment, which involves knot formation of the nerves at the needle tip. This has been associated with the kinking of the metallic, coiled tip into a hooked shape, and it has been postulated that the coils of the curved tip may entrap nerve tissue between them.
The majority of cases in which catheter tip entrapment was involved occurred in the area of the brachial plexus. It is speculated that the complex branching structure of the nerves in that area may increase the risk of the complication. The bare metal surface of the StimuCath catheter has also been implicated in forming adhesions to surrounding tissue, requiring more force to remove it. When excessive force is applied during catheter removal, there is additional concern for neurological damage during separation from the tissue, catheter deformation and component separation.
Attempts to remove entrapped or adherent catheters carry a significant risk of nerve injury. Reports include a patient who suffered permanent injury to the C5 and C6 nerve roots, a case where superior neurological trunk function was lost, and patients who suffer transient pain, persistent paresthesia, and other neurological symptoms. Complications associated with perineural catheters include infection, leaking, migration, kinking, shearing and knotting, and surgical extraction is often required in those cases. The increasing use of postoperative nerve catheters will likely lead to a rise in the presentation of these types of problems.
The first model of StimuCath was approved via 510(k) in 2002. Arrow International was acquired by Teleflex Incorporated in 2007. Arrow StimuCath Continuous Nerve Block Kits were recalled in 2011 and 2014 due to possible compromise in sterility, and Arrow Continuous Nerve Block Needles were recalled in 2005 due to possible over crimping of the needle during manufacturing. If you have any questions, contact Leigh O’Dell, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Leigh.Odell@beasleyallen.com.
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