Indications, Safety, and Warnings OptiSphere Embolization Spheres
OptiSphere™ embolization spheres are intended for use in embolization of hypervascular tumors.
The OptiSphere embolization spheres are provided sterile for single use only. Reuse of a single-use device creates a potential risk of patient or user infections and may compromise device functionality, which may lead to illness or serious patient injury.
OptiSphere embolization spheres should not be used in the presence of infection. Gelatin-based materials may serve as a nidus for infection and abscess formation and have been reported to potentiate bacterial growth.
Do not use the OptiSphere embolization spheres if the packaging is damaged. A damaged package could indicate a breach of sterility or device damage.
Inspect the device for damage prior to use. Use of a damaged device could result in injury.
Prior to delivering OptiSphere embolization spheres, confirm that the selected delivery catheter (not included) meets the minimum required inner diameter for the selected sphere size. Use of a delivery catheter that does not meet the minimum inner diameter requirements may prevent delivery or result in injury.
Prior to delivering OptiSphere embolization spheres, confirm that the catheter is in the desired location. Failure to confirm appropriate catheter placement may result in non-target embolization. OptiSphere embolization spheres are available in a range of sizes and care should be taken to choose the appropriate size for the site intended to be treated. Improper size selection may result in injury.
If the delivery catheter becomes obstructed or significant resistance is encountered during injection, do not attempt to flush the catheter with excessive pressure as non-target embolization may occur.
Potential adverse effects that may be associated with the OptiSphere embolization spheres include, but are not limited to, the following: