This communication comes as part of an FDA pilot to enhance its medical device recall program. The FDA issued its notice after becoming aware of a potentially high-risk device issue.
Calyxo sent affected providers an urgent device field correction notice last month to notify them of updated instructions for use for CVAC. The system (which features an aspiration system and image processor) establishes a channel during endoscopic urological procedures. It aids in the treatment and removal of urinary stones.
The company identified a new risk of injury during the use of the system when patients have thick fluid in the kidney at the start of the procedure. This can cause reduced fluid outflow, which can lead to excessive pressure in the kidney. If left unaddressed, increased pressure in the kidney can lead to serious injury or death.
Calyxo reported one death associated with this issue.
Calyxo provides updated instructions for urologists using the aspiration system
The company notified all urologists using CVAC of the additional instructions. It says to not continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow. Doing so can create an intrarenal pressure imbalance, which may result in serious injury or death. If a patient has cloudy, opaque or suspected thick fluid, stop irrigation immediately using the three-way stopcock.
Urologists should not use the CVAC system if opaque fluid completely obscures visibility within the collection system. Diagnostic or therapeutic ureteroscopy is contraindicated in patients with untreated urinary tract infection. Patients with coagulation disorders, severe cardiopulmonary insufficiency, or uncontrolled diabetes should be managed appropriately.
CVAC has compatibility with 12/14 Fr ureteral access sheaths and will provide limited outflow, which may over-pressure the kidney. If the urologist desires drainage through the access sheath, they should use a 13/15 Fr or larger sheath.
Urologists should also confirm proper setup of their equipment for monitoring fluid outflow when suspecting low outflow.
