Device typeFoetal bladder shunt: A sterile non-bioabsorbable tubular device intended to be implanted in the bladder of a foetus with post-vesicular obstructive uropathy, to decompress the urinary tract by providing a temporary drainage route for urine from the bladder into the amniotic sac, until the defect can be surgically repaired after birth. It is made of synthetic polymer materials and is typically designed with retention features (e.g., double pigtail). It is inserted through the maternal abdominal wall via a percutaneous suprapubic access tract, under ultrasound guidance; disposable devices to assist implantation are typically included.
FDA categoryStent,bladder,fetal
Device ID00827002167667
Catalog numberJ-HFBS-503540
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information