Pressurized Sprayers of Surgical Sealants Can Cause Embolisms

Cheryl A. Thompson

BETHESDA, MD 09 July 2010—FDA on July 9 announced that life-threatening air or gas embolisms have occurred in surgery patients during or immediately after the use of air- or gas-pressurized sprayers to apply hemostatic drugs or biologicals.

The agency said these embolisms are rare events. But one patient has died.

According to FDA's review of reports on the events, the incidents of air or gas embolism seem related to surgeons or operating room personnel using the spray devices in ways inconsistent with the FDA-approved labeling and instructions for use.

Some of the reports, FDA said, mentioned that the air- or gas-pressurized sprayer had been used at a pressure higher than recommended in the labeling or at a distance too close to the surface of the bleeding site.

The agency named seven brands of air- or gas-pressurized sprayers that can mix and apply fibrin sealant or surgical hemostat:

• EasySpray and Spray Set, by Baxter Healthcare Corporation, for use with the Duploject Easy-Prep fibrin sealant preparation and application system,
• Evicel application device, by Omrix Medical,
• FibriJet Aerosol Applicator, by Micromedics Inc.,
• HemaMyst Surgical Applicator System, by Haemacure Corporation,
• MicroMyst Applicator and Air Pump models 20-5000 and AP-A-6063, by Confluent Surgical Inc.,
• Tissomat and Spray Set, by Baxter, for use with the Duploject system, and
• Vitagel Hemostat Spray Set, by Orthovita Inc.

Only the Vitagel product is packaged as a combination of device and hemostatic agent. The surgical hemostat consists of bovine collagen and bovine thrombin.

Baxter's pressurized sprayers are indicated for use with Baxter's fibrin sealants: EasySpray for the application of Artiss, and Tissomat for the application of Tisseel.

Omrix's device is indicated for use with Omrix's Evicel.

Haemacure's HemaMyst is indicated for use with Tisseel fibrin sealant.

The FibriJet and MicroMyst devices are indicated for the simultaneous delivery of two nonhomogeneous fluids to a treatment or surgical site.

FDA said the labeling of the fibrin sealants now includes information on recommended pressures and distances.