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Arrow Sheath Introducers

A member hospital reported a deadly central venous air embolism caused by the separation of a specific manufacturer's side port/hemostasis valve catheter-to-sheath adapter from the same manufacturer's per-cutaneous sheath hub. The incident occurred when the standard Luer-lock fitting disconnected as a patient was moved from a bed to a chair.

Review of FDA problem reporting databases revealed other reports of fatalities due to air embolism, as well as exsanguination, involving the same manufacturer's side port/hemostasis valve adapters from its introducer sheaths. The databases also include numerous other reports of disconnection of the side port/hemostasis valve adapter, many of which were associated with serious injury. In addition, a letter in Anesthesiology discusses two cases of air embolism associated with this manufacturer's vascular access system, one of which was fatal. Exsanguination is the fatal process of total blood loss. Exsanguination is also a cause of human death where injuries which rupture any major blood vessel lead to rapid blood loss which cannot be quickly treated.

Arrow manufactures a medical device called a percutaneous sheath introducer (PSI). The PSI facilitates the insertion of catheters into a patients body. The particular device at issue in this case is a two-piece apparatus. One piece is a long, straight sheath introducer, shaped something like a straw, with a lock on the end. The second piece has a valve that attaches to the end of the sheath lock and a clear plastic tube that dangles from a side port of the valve. The tube has a sealing cap on the end. When the PSI pieces are attached and implanted into a patient, the sheath introducer is placed in the patients vein, usually the jugular vein; the valve remains outside the patient, as does the side tube, which may be used for the introduction of fluids. If a catheter is threaded through the valve and sheath introducer, a catheter guard is often placed around the valve.

Venous air embolism (VAE) is a potentially lethal complication that can occur during any surgical procedure in which the operative site is 5 cm or higher above the right atrium or gas is forced under pressure into a body cavity. Although VAE is typically described as a complication of neurosurgery, it can occur during procedures involving the head and neck, laparoscopic procedures, vaginal delivery and cesarean section, and spinal instrumentation procedures. VAE has been reported to occur during liver transplantation.

Many occurrences of VAE are asymptomatic, entrainment of large quantities of air can lead to cardiovascular collapse, severe neurologic injury, and death. The incidence of VAE is highest for neurosurgical procedures in the sitting position; the incidence ranges from 10% for cervical laminectomy to 80% of patients undergoing craniotomy in the sitting position.

If you or a loved one suffered injuries from an Arrow Sheath Introducer, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.